Material, Tooth Shade, Resin
The Tooth Shade Resin Material is a dental restorative material formulated to closely match the color and translucency of natural tooth structure, used for direct or indirect restorations where esthetics are a primary requirement. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is EBF and the applicable regulation is 21 CFR 872.3690, under the Dental medical specialty. This device is eligible for third-party 510(k) review.
Basic Information
- Product Code
- EBF
- Device Class
- FDA class 2
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 914 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251283 | Once-Fil Flow | Jun 06, 2025 | Substantially Equivalent | Mediclus Co., Ltd. |
| K250317 | EsFlow PLUS | May 30, 2025 | Substantially Equivalent | Spident CO. LTD |
| K251578 | BEAUTIFIL II | May 27, 2025 | Substantially Equivalent | Shofu Dental Corporation |
| K250778 | Sil-Flow | May 23, 2025 | Substantially Equivalent | DSI Dental Solutions Ltd |
| K251239 | GrandioSO Unlimited | May 21, 2025 | Substantially Equivalent | VOCO GmbH |
| K250763 | Reon | May 12, 2025 | Substantially Equivalent | C.E.I.B.med |
| K250497 | Additive Manufacturing (Light Curing) Crown Bridge Resin | Apr 30, 2025 | Substantially Equivalent | Aidite (Qinhuangdao) Technology Co., Ltd |
| K250823 | Any-Com Flow | Apr 14, 2025 | Substantially Equivalent | Mediclus Co., Ltd. |
| K250267 | Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) | Mar 14, 2025 | Substantially Equivalent | Kettenbach GmbH & Co. KG |
| K242713 | Any-Com Bulk | Feb 07, 2025 | Substantially Equivalent | MEDICLUS CO., LTD. |
| K242572 | TopCEM-Try in Veneer Try-in Gel | Dec 20, 2024 | Substantially Equivalent | Rizhao HuGe Biomaterials Company, Ltd. |
| K243720 | 3Delta UNlimited | Dec 18, 2024 | Substantially Equivalent | DeltaMed GmbH |
| K242816 | Quantium | Dec 17, 2024 | Substantially Equivalent | Bisco, Inc. |
| K233273 | C&B Ceramic; C&B Permanent; C&B Interim | Nov 27, 2024 | Substantially Equivalent | Prevest Denpro Limited |
| K241131 | edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK | Oct 18, 2024 | Substantially Equivalent | Edelweiss Dentistry Products GmbH |
| K232994 | Vittra APS Unique Flow | Oct 18, 2024 | Substantially Equivalent | Dentscare LTDA |
| K242097 | DenMat Bulk Fill Composite | Oct 15, 2024 | Substantially Equivalent | Den-Mat Holdings, LLC |
| K241673 | Denture Base Resin (PN-Denture (Red, White)) | Oct 15, 2024 | Substantially Equivalent | Shenzhen Piocreat 3D Technology Co., Ltd. |
| K242014 | Jet Flow Bulk | Oct 08, 2024 | Substantially Equivalent | META Biomed Co., Ltd. |
| K242277 | Crown HT | Oct 01, 2024 | Substantially Equivalent | SprintRay Inc. |
| K241147 | Any-Com | Sep 26, 2024 | Substantially Equivalent | Mediclus Co., Ltd. |
| K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active | Sep 17, 2024 | Substantially Equivalent | Kulzer, LLC |
| K232559 | C&B NFH Hybrid | Sep 11, 2024 | Substantially Equivalent | Arum Dentistry Co., Ltd. |
| K240823 | els extra low shrinkage® composite & els extra low shrinkage® flow | Jun 27, 2024 | Substantially Equivalent | Saremco Dental AG |
| K231142 | Temporis, Irix Plus | Apr 25, 2024 | Substantially Equivalent | DWS s.r.l. |
| K240694 | FORMA Composite (Shade A3D) | Mar 15, 2024 | Substantially Equivalent | Ultradent Products, Inc. |
| K240112 | Light Cure Composite | Mar 15, 2024 | Substantially Equivalent | Sincera Technology (Changchun) Co., Ltd. |
| K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT | Jan 05, 2024 | Substantially Equivalent | Prevest Denpro Limited |
| K233082 | TopCEM Dual Cure Resin Cement | Dec 22, 2023 | Substantially Equivalent | Rizhao HuGe Biomaterials Company, Ltd. |
| K232050 | saremco print BRIDGETEC | Nov 14, 2023 | Substantially Equivalent | Saremco Dental AG |
| K233596 | VarseoSmile TriniQ | Nov 09, 2023 | Substantially Equivalent | BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG |
| K233502 | TERA HARZ II | Nov 01, 2023 | Substantially Equivalent | Graphy Inc. |
| K230644 | Signum opaque F | Sep 07, 2023 | Substantially Equivalent | Kulzer, LLC |
| K231523 | EsCom250 | Jul 24, 2023 | Substantially Equivalent | Spident Co., Ltd. |
| K230877 | Admira Fusion 5 | Jul 13, 2023 | Substantially Equivalent | VOCO GmbH |
| K223742 | Dental Ceramic Blocks | Mar 08, 2023 | Substantially Equivalent | Aidite (Qinhuangdao) Technology Co., Ltd |
| K222445 | LC ChromeFlow | Mar 06, 2023 | Substantially Equivalent | S&C Polymer Silicon- und Composite Spezialitaten GmbH |
| K222623 | Digital Crown | Dec 14, 2022 | Substantially Equivalent | SprintRay Inc. |
| K223632 | Premier's MultiMatch Universal Chameleon Restorative Composite | Dec 06, 2022 | Substantially Equivalent | Premier Dental Products Company |
| K222583 | Stela Capsule System | Oct 28, 2022 | Substantially Equivalent | SDI Limited |
| K222581 | Stela Automix System | Oct 28, 2022 | Substantially Equivalent | SDI Limited |
| K221510 | TrusFIL-Flow Flowable Composite Restorative | Oct 12, 2022 | Substantially Equivalent | Rizhao HuGe Biomaterials Company, Ltd. |
| K222435 | Renamel® Microhybrid ;Renamel® Flowable Microhybrid | Oct 11, 2022 | Substantially Equivalent | Cosmedent, Inc |
| K222877 | FREEPRINT crown | Sep 23, 2022 | Substantially Equivalent | DETAX GmbH |
| K213339 | DENU Composite Resin, DENU Flow Resin | Sep 23, 2022 | Substantially Equivalent | HDI, Inc. |
| K222723 | AMBARINO High-Class | Sep 09, 2022 | Substantially Equivalent | Creamed GmbH & Co. Produktions- und Handels KG |
| K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow | Aug 31, 2022 | Substantially Equivalent | Kerr Corporation |
| K220329 | G-CAM | Aug 16, 2022 | Substantially Equivalent | Graphenano Dental S.L. |
| K220077 | IMICRYL Composite, Composite Flow Materials | Aug 09, 2022 | Substantially Equivalent | IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS |
| K221909 | J-Temp | Jul 01, 2022 | Substantially Equivalent | Ultradent Products, Inc. |
| K221695 | 3M Filtek Supreme Flowable Restorative | Jun 13, 2022 | Substantially Equivalent | 3M Company ESPE Dental Products |
| K202920 | OptiComp | May 25, 2022 | Substantially Equivalent | Pac-Dent, Inc. |
| K220605 | Venus Bulk Flow ONE | Apr 21, 2022 | Substantially Equivalent | Kulzer, LLC |
| K213343 | Saremco Print CROWNTEC | Jan 21, 2022 | Substantially Equivalent | Saremco Dental AG |
| K211804 | 3Delta Crown | Dec 06, 2021 | Substantially Equivalent | DeltaMed GmbH |
| K211345 | C-30 Crown Kit | Nov 24, 2021 | Substantially Equivalent | Perfect Fit Crowns, LLC |
| K210231 | Vittra APS Unique | Oct 14, 2021 | Substantially Equivalent | Dentscare Ltda |
| K202063 | TrusFIL Universal Composite Restorative | Oct 06, 2021 | Substantially Equivalent | Rizhao HuGe Biomaterials Company, Ltd. |
| K210045 | ACTIVA PRESTO PACK | Sep 22, 2021 | Substantially Equivalent | Pulpdent Corporation |
| K210412 | Pac-Dent Ceramic Nanohybrid Resin | Jul 26, 2021 | Substantially Equivalent | Pac-Dent, Inc. |
| K210349 | TKO Composite Bite Turbo Gel | Jul 20, 2021 | Substantially Equivalent | Reliance Orthodontic Products, Inc |
| K202846 | TERA HARZ | Jul 15, 2021 | Substantially Equivalent | Graphy Inc. |
| K210421 | Diafil & Diafil Capsule | Jun 28, 2021 | Substantially Equivalent | Diadent Group International |
| K211259 | Renamel Bulkfill | Jun 24, 2021 | Substantially Equivalent | Cosmedent, Inc |
| K210977 | E-Dent 1000 | May 25, 2021 | Substantially Equivalent | EnvisionTEC GmbH |
| K200470 | Shofu Block HC Hard | Feb 05, 2021 | Substantially Equivalent | Shofu Dental Corporation |
| K203598 | Omnichroma Flow Bulk | Feb 03, 2021 | Substantially Equivalent | Tokuyama Dental Corporation |
| K201707 | Opallis, Opallis Flow | Dec 22, 2020 | Substantially Equivalent | Dentscare LTDA |
| K200155 | Bright High Flow | Nov 30, 2020 | Substantially Equivalent | GENOSS Co., Ltd. |
| K200156 | Bright Low Flow | Oct 27, 2020 | Substantially Equivalent | Genoss co.,Ltd. |
| K201795 | Transcend | Sep 28, 2020 | Substantially Equivalent | Ultradent Product, Inc. |
| K193537 | Omnichroma Flow | Aug 19, 2020 | Substantially Equivalent | Tokuyama Dental Corporation |
| K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite | Aug 14, 2020 | Substantially Equivalent | Nobio Ltd. |
| K201307 | VisCalor | Jul 08, 2020 | Substantially Equivalent | VOCO GmbH |
| K201668 | VarseoSmile Crown plus | Jun 23, 2020 | Substantially Equivalent | BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG |
| K193496 | CharmFil | May 06, 2020 | Substantially Equivalent | Dentkist, Inc. |
| K190139 | Zircos-Com | Apr 24, 2020 | Substantially Equivalent | Bioden Co., Ltd |
| K200294 | GrandioSO Light Flow | Mar 27, 2020 | Substantially Equivalent | VOCO GmbH |
| K192284 | DiaFil Flow | Mar 25, 2020 | Substantially Equivalent | Diadent Group International |
| K192510 | DIAFIL & DIAFIL Capsule | Mar 20, 2020 | Substantially Equivalent | Diadent Group International |
| K191991 | Ezfil | Mar 05, 2020 | Substantially Equivalent | Meta Biomed Co., Ltd. |
| K191389 | Allcem Veneer APS | Feb 25, 2020 | Substantially Equivalent | Dentscare Ltda |
| K192178 | R&D Series Nova Compo N | Dec 20, 2019 | Substantially Equivalent | Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. |
| K191306 | Llis, Vittra APS | Dec 16, 2019 | Substantially Equivalent | Dentscare LTDA |
| K192260 | everX Flow | Nov 22, 2019 | Substantially Equivalent | GC America Inc. |
| K191980 | CLEARFIL MAJESTY ES Flow | Nov 18, 2019 | Substantially Equivalent | Kuraray Noritake Dental Inc. |
| K191385 | BRILLIANT COMPONEER | Oct 29, 2019 | Substantially Equivalent | Coltene/Whaledent AG |
| K182921 | Infinix Universal Composite | Sep 13, 2019 | Substantially Equivalent | Nobio Ltd. |
| K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APS | Sep 04, 2019 | Substantially Equivalent | DentsCare LTDA |
| K182714 | Novidia Bulk Fill Flow Composite | Jul 12, 2019 | Substantially Equivalent | Nobio Ltd. |
| K182780 | XP Composite | Jul 03, 2019 | Substantially Equivalent | S&C Polymer Silicon- und Composite Spezialitaeten GmbH |
| K182580 | Novidia Flowable Composite | Jul 03, 2019 | Substantially Equivalent | Nobio Ltd. |
| K190597 | BRILLIANT EverGlow Flow | Jun 21, 2019 | Substantially Equivalent | Coltene/Whaledent AG |
| K182430 | CLEARFIL MAJESTY IC | May 03, 2019 | Substantially Equivalent | Kuraray Noritake Dental Inc. |
| K182778 | LC GLOSSFILL XR | Apr 22, 2019 | Substantially Equivalent | S&C Polymer Silicon- und Composite Spezialitaeten GmbH |
| K190453 | VisCalor bulk | Apr 11, 2019 | Substantially Equivalent | VOCO GmbH |
| K183380 | Tetric PowerFill | Mar 14, 2019 | Substantially Equivalent | Ivoclar Vivadent, AG |
| K182869 | Fit SA | Jan 09, 2019 | Substantially Equivalent | Shofu Dental Corporation |
| K183476 | 3M Filtek Universal Restorative | Jan 02, 2019 | Substantially Equivalent | 3M ESPE Dental Products |
| K182296 | HyperFil-LV | Dec 14, 2018 | Substantially Equivalent | Parkell, Inc. |
| K182288 | TPH Spectra ST Flowable Composite Restorative | Nov 20, 2018 | Substantially Equivalent | Dentsply Sirona |
| K181689 | Nexcomp | Nov 15, 2018 | Substantially Equivalent | Meta Biomed Co., Ltd. |
| K180463 | Apoller Flow Light Cure Flowable Composite | Nov 14, 2018 | Substantially Equivalent | Greenway YW LLC |
| K181312 | GrandioSO x-tra | Aug 22, 2018 | Substantially Equivalent | VOCO GmbH |
| K181500 | BRILLIANT Crios | Aug 15, 2018 | Substantially Equivalent | Coltene/Whaledent AG |
| K180613 | Estelite Universal Flow | Jul 12, 2018 | Substantially Equivalent | Tokuyama Dental Corporation |
| K172952 | Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit | Jul 03, 2018 | Substantially Equivalent | Figaro Crowns, Inc. |
| K181484 | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue | Jun 18, 2018 | Substantially Equivalent | Zirkonzahn Srl |
| K180649 | BeautiCem Veneer Kit | Jun 11, 2018 | Substantially Equivalent | Shofu Dental Corporation |
| K173573 | Tetric CAD | Jun 07, 2018 | Substantially Equivalent | Ivoclar Vivadent AG |
| K173500 | NMF004A | Mar 08, 2018 | Substantially Equivalent | GC America Inc. |
| K173275 | OMNICHROMA | Feb 27, 2018 | Substantially Equivalent | Tokuyama Dental Corporation |
| K173643 | Trilor Disks, Blocks and Arches | Feb 24, 2018 | Substantially Equivalent | Bioloren S.R.L. |
| K171772 | Ecosite Bulk Fill | Jan 31, 2018 | Substantially Equivalent | DMG USA Inc. |
| K173124 | PEEK Biosolution | Dec 18, 2017 | Substantially Equivalent | Merz Dental GmbH |
| K172530 | BEAUTIFIL Flow Plus X | Dec 06, 2017 | Substantially Equivalent | Shofu Dental Corporation |
| K172707 | Renamel Microfill | Dec 05, 2017 | Substantially Equivalent | Cosmedent, Inc |
| K171815 | Registrado Scan | Nov 15, 2017 | Substantially Equivalent | VOCO GmbH |
| K170102 | Pekkton Ivory | Nov 13, 2017 | Substantially Equivalent | CENDRES+METAUX SA |
| K170873 | Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl | Oct 02, 2017 | Substantially Equivalent | SwissMediTec GmbH |
| K171200 | Grandio blocs | Aug 10, 2017 | Substantially Equivalent | VOCO GmbH |
| K171147 | REVEAL Bulk | Aug 04, 2017 | Substantially Equivalent | Bisco, Inc. |
| K170896 | Admira Fusion x-base | Jun 29, 2017 | Substantially Equivalent | VOCO GmbH |
| K161353 | ESTELITE BULK FILL Flow | Apr 03, 2017 | Substantially Equivalent | TOKUYAMA DENTAL CORPORATION |
| K162967 | nuance UNIVERSAL | Mar 24, 2017 | Substantially Equivalent | Den-Mat Holdings, LLC |
| K163346 | MAZIC Duro | Mar 17, 2017 | Substantially Equivalent | VERICOM CO., LTD. |
| K163480 | Renamel NANO +plus | Feb 24, 2017 | Substantially Equivalent | Cosmedent, Inc |
| K162323 | Tooth Shade Resin Material | Jan 12, 2017 | Substantially Equivalent | LIAONING UPCERA CO.,LTD |
| K162261 | CERAMAGE UP | Jan 11, 2017 | Substantially Equivalent | SHOFU DENTAL CORPORATION |
| K163207 | Filtek One Bulk Fill Restorative | Nov 28, 2016 | Substantially Equivalent | 3M Company |
| K162537 | CAD/CAMouflage Milling Block | Nov 16, 2016 | Substantially Equivalent | PRISMATIK DENTALCRAFT, INC. |
| K160049 | Charisma | Nov 15, 2016 | Substantially Equivalent | Heraeus Kulzer, LLC (Mitsui Chemicals Group) |
| K162257 | P1145 Dental Restorative | Nov 07, 2016 | Substantially Equivalent | Kerr Corporation |
| K151399 | Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow | Oct 24, 2016 | Substantially Equivalent | SCHUTZ DENTAL GMBH |
| K162107 | TPH Spectra+ Universal Composite Restorative | Sep 27, 2016 | Substantially Equivalent | DENTSPLY SIRONA |
| K153476 | KATANA AVENCIA Block | Aug 23, 2016 | Substantially Equivalent | Kuraray Noritake Dental, Inc. |
| K152471 | CAPO BULK FILL | Aug 04, 2016 | Substantially Equivalent | SCHUETZ DENTAL GMBH |
| K153493 | Clip Flow | Jul 29, 2016 | Substantially Equivalent | VOCO GmbH |
| K160596 | BEAUTIFIL II LS | Jul 27, 2016 | Substantially Equivalent | SHOFU DENTAL CORPORATION |
| K160086 | SHOFU Enamel Conditioner | Jul 21, 2016 | Substantially Equivalent | SHOFU DENTAL CORPORATION |
| K152113 | BioHPP - breCAM.BioHPP | Jul 21, 2016 | Substantially Equivalent | Bredent GmbH & Co.KG |
| K160425 | CAD/CAMouflage Milling Bock | Jul 15, 2016 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K153325 | Gradia Plus | Jul 12, 2016 | Substantially Equivalent | GC America Inc. |
| K153177 | Admira Fusion Flow | Jun 30, 2016 | Substantially Equivalent | VOCO GMBH |
| K153127 | everX Posterior | May 20, 2016 | Substantially Equivalent | GC AMERICA INC. |
| K152927 | BRILLIANT EVERGLOW | Apr 28, 2016 | Substantially Equivalent | COLTENE/WHALEDENT AG |
| K153249 | Pulpdent Solo Flowable Composite with MCP | Apr 01, 2016 | Substantially Equivalent | Pulpdent Corporation |
| K151700 | BEAUTIFIL II Gingiva | Mar 02, 2016 | Substantially Equivalent | SHOFU DENTAL CORPORATION |
| K153191 | Calcium Bridge | Feb 26, 2016 | Substantially Equivalent | DENALI CORPORATION |
| K152373 | VITA VM LC Flow | Dec 30, 2015 | Substantially Equivalent | VITA ZAHNFABRIK H. RAUTER GMBH & CO. |
| K151699 | BEAUTIFIL II Enamel | Dec 10, 2015 | Substantially Equivalent | SHOFU DENTAL CORPORATION |
| K152004 | Nanova Universal Composite | Nov 17, 2015 | Substantially Equivalent | NANOVA BIOMATERIALS INC |
| K151956 | Admira Fusion x-tra | Oct 20, 2015 | Substantially Equivalent | VOCO GMBH |
| K151541 | G-Fix | Oct 09, 2015 | Substantially Equivalent | GC America Inc. |
| K151514 | Prestige | Sep 21, 2015 | Substantially Equivalent | DANVILLE MATERIALS LLC |
| K151088 | DMRC Bulk Fill | Aug 28, 2015 | Substantially Equivalent | DANVILLE MATERIALS, LLC |
| K151094 | Mosaic Universal Composite | Jul 21, 2015 | Substantially Equivalent | ULTRADENT PRODUCTS, INC. |
| K150784 | Admira Fusion | Jul 02, 2015 | Substantially Equivalent | VOCO GMBH |
| K150218 | Fill-Up! | Jun 23, 2015 | Substantially Equivalent | COLTENE/WHALEDENT AG |
| K150623 | Nanova Flowable Composite | Jun 18, 2015 | Substantially Equivalent | NANOVA BIOMATERIALS, INC. |
| K150393 | TETRIC EVOFLOW BULK FILL | Jun 09, 2015 | Substantially Equivalent | IVOCLAR VIVADENT AG |
| K143524 | Fiber Disks and Blocks (TRINIA) | Jun 02, 2015 | Substantially Equivalent | Bicon, LLC |
| K143694 | Rhondium One-Visit-Crown(OVC) | May 15, 2015 | Substantially Equivalent | Rhondium, Ltd. |
| K143679 | Nuance FLOW | May 01, 2015 | Substantially Equivalent | Den-Mat Holdings, LLC |
| K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X | Mar 25, 2015 | Substantially Equivalent | KETTENBACH GMBH & CO KG |
| K143209 | SonicFill 2 | Feb 05, 2015 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES |
| K142389 | Variolink Esthetic | Nov 25, 2014 | Substantially Equivalent | IVOCLAR VIVADENT AG |
| K141994 | BULK FILL FLOWABLE COMPOSITE | Nov 14, 2014 | Substantially Equivalent | NOVOCOL, INC. |
| K140976 | ENADEN FLOW | Jul 10, 2014 | Substantially Equivalent | KM CORPORATION |
| K140512 | UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE | Jul 02, 2014 | Substantially Equivalent | JUNO DENTISTRY LP |
| K132115 | ABSOLUTE DENTIN 2 | Jun 25, 2014 | Substantially Equivalent | PARKELL, INC. |
| K133850 | CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE) | Jun 04, 2014 | Substantially Equivalent | PRISMATIK DENTALCRAFT, INC. |
| K141081 | FILTEK BULK FILL POSTERIOR RESTROATIVE | May 08, 2014 | Substantially Equivalent | 3M ESPE DENTAL PRODUCTS |
| K133182 | HTFX-222 | Apr 09, 2014 | Substantially Equivalent | GC AMERICA, INC. |
| K133824 | CERASMART | Mar 14, 2014 | Substantially Equivalent | GC AMERICA, INC. |
| K133608 | TRINIA | Mar 14, 2014 | Substantially Equivalent | BICON, LLC |
| K132748 | BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK | Dec 04, 2013 | Substantially Equivalent | SHOFU DENTAL CORPORATION |
| K131753 | MERIDIAN | Nov 14, 2013 | Substantially Equivalent | AB ARDENT |
| K132141 | BEAUTIFIL BULK FLOWABLE | Oct 03, 2013 | Substantially Equivalent | SHOFU DENTAL CORPORATION |
| K130841 | SHOFU BLOCK HC | Sep 11, 2013 | Substantially Equivalent | SHOFU DENTAL CORPORATION |
| K130672 | OPTIFLOW II FLOWABLE COMPOSITE, LC | Aug 13, 2013 | Substantially Equivalent | PAC-DENT INTERNATIONAL, INC. |
| K123631 | MFP-051 | Jul 23, 2013 | Substantially Equivalent | GC AMERICA, INC. |
| K131504 | UNIVERSAL OPAQUE | Jul 16, 2013 | Substantially Equivalent | SHOFU DENTAL CORPORATION |
| K123823 | INTERLIG | May 31, 2013 | Substantially Equivalent | ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS |
| K130371 | CLEARFIL MAJESTY ES FLOW | Apr 09, 2013 | Substantially Equivalent | KURARAY NORITAKE DENTAL INC. |
| K121769 | DENTOCORE / DENTOCORE BODY | Mar 05, 2013 | Substantially Equivalent | ITENA CLINICAL |
| K121735 | FIBER DISK AND BLOCK PERMANENT, TRINIA | Feb 21, 2013 | Substantially Equivalent | BIOLOREN SRL |
| K123397 | MULTILINK AUTOMIX | Jan 31, 2013 | Substantially Equivalent | IVOCLAR VIVADENT AG |
| K123304 | SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO | Jan 24, 2013 | Substantially Equivalent | IVOCLAR VIVADENT AG |
| K123773 | X-TRA BASE | Dec 21, 2012 | Substantially Equivalent | VOCO GMBH |
| K120237 | BPA-FREE MICROHYBID COMPOSITE | Dec 11, 2012 | Substantially Equivalent | NOVOCOL, INC. |
| K121915 | BRIGHT RESTORATIVE MATERIALS | Sep 28, 2012 | Substantially Equivalent | DMP LTD |
| K121880 | DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID | Sep 25, 2012 | Substantially Equivalent | DANVILLE MATERIALS, INC. |
| K122569 | LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR | Sep 12, 2012 | Substantially Equivalent | 3M COMPANY |
| K121230 | IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE | Aug 29, 2012 | Substantially Equivalent | IVOCLAR VIVADENT AG |
| K121583 | CLEARFIL MAJESTY FLOW | Jul 25, 2012 | Substantially Equivalent | KURARAY NORITAKE DENTAL INC. |
| K120768 | ES FLOW | May 03, 2012 | Substantially Equivalent | SPIDENT CO., LTD. |
| K120453 | FILTEK BULK FILL FLOWABLE RESTORATIVE | Mar 19, 2012 | Substantially Equivalent | 3M ESPE DENTAL PRODUCTS |
| K113617 | SPEE-DEE PATCH | Mar 02, 2012 | Substantially Equivalent | PULPDENT CORPORATION |
| K112044 | ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A | Jan 26, 2012 | Substantially Equivalent | ANAXDENT GMBH |
| K113563 | N-HYBRIDE-COMPOSITE LC | Dec 21, 2011 | Substantially Equivalent | VOCO GMBH |
| K113444 | N-HYBRIDE-COMPOSITE LC FLOW | Dec 21, 2011 | Substantially Equivalent | VOCO GMBH |
| K112501 | VENUS PEARL PLT REFILL A1 | Dec 14, 2011 | Substantially Equivalent | HERAEUS KULZER, LLC |
| K112168 | COMPONEER | Nov 21, 2011 | Substantially Equivalent | COLTENE/WHALEDENT AG |
| K111982 | CLEARFIL DC CORE PLUS | Nov 17, 2011 | Substantially Equivalent | KURARAY AMERICA, INC. |
| K112447 | GRANDIO CORE DUAL CURE | Nov 08, 2011 | Substantially Equivalent | VOCO GMBH |
| K112374 | X-TRA BASE | Oct 20, 2011 | Substantially Equivalent | VOCO GMBH |
| K111958 | TETRIC EVOCERAM BULK FILL | Oct 14, 2011 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K110859 | METAL OPAQUER | Jun 23, 2011 | Substantially Equivalent | APEX DENTAL MATERIALS, INC. |
| K110642 | SILJETR SYSTEM | May 27, 2011 | Substantially Equivalent | DANVILLE MATERIALS INC. |
| K110589 | CIMARA | May 27, 2011 | Substantially Equivalent | VOCO GMBH |
| K110178 | ESTELITE COLOR | Apr 05, 2011 | Substantially Equivalent | TOKUYAMA DENTAL CORPORATION |
| K110428 | ESCOM 100 | Feb 25, 2011 | Substantially Equivalent | SPIDENT CO., LTD. |
| K103528 | IPS EMPRESS DIRECT FLOW | Feb 25, 2011 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K103190 | PROFIL COMPOSITES (PROFIL, PROFIL FLOW) | Feb 02, 2011 | Substantially Equivalent | SILMET LTD. |
| K110131 | LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE | Jan 21, 2011 | Substantially Equivalent | 3M ESPE DENTAL PRODUCTS |
| K103580 | GRANDIO SO FLOW | Jan 21, 2011 | Substantially Equivalent | VOCO GMBH |
| K103351 | DMC COMPOSITE 2 | Jan 20, 2011 | Substantially Equivalent | KERR CORPORATION |
| K102703 | BUILD-IT TOTAL CORE | Jan 05, 2011 | Substantially Equivalent | PENTRON CLINICAL |
| K102984 | AURA | Dec 08, 2010 | Substantially Equivalent | SDI LIMITED |
| K102255 | DMP ETCHING GEL | Nov 23, 2010 | Substantially Equivalent | DMP LTD |
| K102257 | NANOCERAM- BRIGHT | Nov 19, 2010 | Substantially Equivalent | DMP LTD |
| K102603 | SA FLOWABLE ADHESIVE | Nov 17, 2010 | Substantially Equivalent | DMG USA, INC. |
| K102354 | GRANDIO SO HEAVY FLOW | Nov 08, 2010 | Substantially Equivalent | VOCO GMBH |
| K102351 | GRANDIO SO | Nov 02, 2010 | Substantially Equivalent | VOCO GMBH |
| K101540 | GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE | Oct 29, 2010 | Substantially Equivalent | NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC |
| K102526 | BLO2X OXYGEN BLOCKER | Oct 22, 2010 | Substantially Equivalent | PASCAL CO., INC. |
| K102450 | IONOLUX PRO | Oct 08, 2010 | Substantially Equivalent | VOCO GMBH |
| K101621 | LITE ART | Aug 23, 2010 | Substantially Equivalent | SHOFU DENTAL CORP. |
| K101603 | BEAUTIFIL FLOW PLUS | Aug 23, 2010 | Substantially Equivalent | SHOFU DENTAL CORP. |
| K101213 | GRANDIO FLOW | Aug 19, 2010 | Substantially Equivalent | VOCO GMBH |
| K101215 | NUANCE | May 12, 2010 | Substantially Equivalent | DISCUS DENTAL, LLC |
| K100235 | FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE | May 12, 2010 | Substantially Equivalent | 3M COMPANY |
| K100083 | ESTHETICA | Mar 19, 2010 | Substantially Equivalent | KERR CORPORATION |
| K100328 | CLEARFIL MAJETY POSTERIOR | Mar 05, 2010 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K100413 | TEMP IT | Mar 03, 2010 | Substantially Equivalent | SPIDENT CO., LTD. |
| K093470 | CORE-FLO D/C | Feb 17, 2010 | Substantially Equivalent | BISCO, INC. |
| K093484 | PREMISE FLOWABLE MODIFIED | Jan 27, 2010 | Substantially Equivalent | KERR CORPORATION |
| K092912 | STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150 | Dec 16, 2009 | Substantially Equivalent | DANVILLE MATERIALS, INC. |
| K092730 | COSMEDENT BRUSHABLE COMPOSITE | Nov 20, 2009 | Substantially Equivalent | COSMEDENT, INC. |
| K092501 | LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL | Nov 12, 2009 | Substantially Equivalent | NOVOCOL, INC. |
| K091512 | BUILD-IT LIGHT CURE | Oct 30, 2009 | Substantially Equivalent | PENTRON CLINICAL TECHNOLOGIES |
| K092281 | CLEARFIL MAJESTY POSTERIOR PLT | Oct 27, 2009 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K091091 | SONICFILL 2010 | Oct 14, 2009 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K092539 | SEAMFREE | Oct 01, 2009 | Substantially Equivalent | APEX DENTAL MATERIALS, INC. |
| K091647 | INJECTAFIL | Sep 21, 2009 | Substantially Equivalent | APEX DENTAL MATERIALS, INC. |
| K092572 | CORE*IT DUAL | Aug 26, 2009 | Substantially Equivalent | SPIDENT CO., LTD. |
| K091388 | GCUC-505 | Jul 22, 2009 | Substantially Equivalent | GC AMERICA, INC. |
| K090843 | AMARIS GINGIVA OPAQUER | Jun 17, 2009 | Substantially Equivalent | VOCO GMBH |
| K090704 | MULTILINK IMPLANT | Jun 17, 2009 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K090747 | MI FLOW (GCUC-450) | Jun 10, 2009 | Substantially Equivalent | GC AMERICA, INC. |
| K091023 | METAMORPHOSIS | May 21, 2009 | Substantially Equivalent | KERR CORPORATION |
| K090391 | PULPDENT MICRO-HYBRID COMPOSITE | May 11, 2009 | Substantially Equivalent | PULPDENT CORPORATION |
| K090701 | EMPRESS DIRECT | Apr 29, 2009 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K083841 | ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL | Apr 14, 2009 | Substantially Equivalent | DENTSPLY INTERNATIONAL, INC. |
| K090292 | PREMISE MODIFIED | Apr 03, 2009 | Substantially Equivalent | KERR CORP. |
| K083326 | FLUOROCORE 2 | Feb 10, 2009 | Substantially Equivalent | DENTSPLY INTERNATIONAL, INC. |
| K083610 | FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE | Dec 17, 2008 | Substantially Equivalent | 3M COMPANY |
| K082671 | HERCULITE ULTRA | Dec 11, 2008 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES |
| K082434 | GDLS-200 | Nov 14, 2008 | Substantially Equivalent | GC AMERICA, INC. |
| K082171 | GRADIA CORE | Oct 30, 2008 | Substantially Equivalent | GC AMERICA, INC |
| K081695 | DMC COMPOSITE | Aug 12, 2008 | Substantially Equivalent | KERR CORP. |
| K073047 | APROXI 1100 AND 4000 SERIES DENTAL INLAYS | Aug 07, 2008 | Substantially Equivalent | APROXI APS |
| K080940 | ESTELITE SIGMA QUICK | Jun 19, 2008 | Substantially Equivalent | TOKUYAMA DENTAL CORPORATION |
| K080478 | GRADIA FORTE | Jun 05, 2008 | Substantially Equivalent | GC AMERICA, INC. |
| K080480 | NANOCOMPOSITE RESTORATIVE KIT | May 30, 2008 | Substantially Equivalent | DMG USA, INC. |
| K080305 | NEXCOMP AND META ETCHANT | Apr 07, 2008 | Substantially Equivalent | META BIOMED CO., LTD. |
| K080068 | BEAUTIFIL OPAQUER | Feb 28, 2008 | Substantially Equivalent | SHOFU DENTAL CORP. |
| K072733 | 3M ESPE ADULT CROWN | Feb 15, 2008 | Substantially Equivalent | 3M COMPANY |
| K080265 | DENFIL ETCHANT-37 | Feb 06, 2008 | Substantially Equivalent | VERICOM CO., LTD. |
| K073554 | NEUN | Feb 04, 2008 | Substantially Equivalent | HERAEUS KULZER GMBH |
| K072746 | E-1 ESTHETIC COMPOSITE SYSTEM | Dec 04, 2007 | Substantially Equivalent | TOKUYAMA DENTAL CORPORATION |
| K072545 | ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 | Oct 26, 2007 | Substantially Equivalent | PENTRON CLINICAL TECHNOLOGIES |
| K072069 | SPACER | Sep 28, 2007 | Substantially Equivalent | VERICOM CO., LTD. |
| K072150 | DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL | Sep 13, 2007 | Substantially Equivalent | NOVOCOL, INC. |
| K071742 | BEAUTIFIL II | Aug 15, 2007 | Substantially Equivalent | SHOFU DENTAL CORP. |
| K071288 | MODIFICATION TO KAVO QUATTROCARE | Jul 19, 2007 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K071278 | EMBRACE DUAL CURE COMPOSITE MATERIALS | Jun 29, 2007 | Substantially Equivalent | PULPDENT CORPORATION |
| K071169 | CLEARFIL MAJESTY POSTERIOR PLT | Jun 20, 2007 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K071386 | AMARIS/AMARIS FLOW | Jun 05, 2007 | Substantially Equivalent | VOCO GMBH |
| K070702 | FUSION RESIN CEMENT AND CORE KIT | May 10, 2007 | Substantially Equivalent | DENALI CORPORATION |
| K070693 | AURAVUE PIT & FISSURE SEALANT | May 09, 2007 | Substantially Equivalent | DENALI CORPORATION |
| K070583 | NANO COMPOSITE | Apr 16, 2007 | Substantially Equivalent | COSMEDENT, INC. |
| K070325 | CLEARFIL MAJESTY ESTHETIC PLT | Mar 21, 2007 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K070190 | GRADIA DIRECT X | Mar 12, 2007 | Substantially Equivalent | GC AMERICA INC. |
| K070191 | ALPHA-CORE DC | Mar 07, 2007 | Substantially Equivalent | DENTAL TECHNOLOGIES, INC. |
| K063595 | CLEARFIL MAJESTY POSTERIOR | Feb 09, 2007 | Substantially Equivalent | KURARAY AMERICA, INC. |
| K063593 | CLEARFIL MAJESTY FLOW | Feb 02, 2007 | Substantially Equivalent | KURARAY AMERICA, INC. |
| K063714 | AXCEL FLOW | Jan 31, 2007 | Substantially Equivalent | TRI DENTAL INNOVATORS |
| K063604 | TWINKY STAR NF | Jan 22, 2007 | Substantially Equivalent | VOCO GMBH |
| K062345 | CERAMIC BOND | Dec 15, 2006 | Substantially Equivalent | VOCO GMBH |
| K062518 | CELERITY | Dec 04, 2006 | Substantially Equivalent | PARKELL, INC. |
| K062515 | RETENTION FLOW OPAQUE | Nov 22, 2006 | Substantially Equivalent | HERAEUS KULZER GMBH |
| K062906 | ENA HFO COMPOSITE SYSTEM | Nov 17, 2006 | Substantially Equivalent | MICERIUM S.P.A. |
| K062409 | K-ETCHANT GEL | Nov 08, 2006 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K062343 | GRANDIO FLOW TRY-IN | Nov 02, 2006 | Substantially Equivalent | VOCO GMBH |
| K062157 | CONFORM | Oct 13, 2006 | Substantially Equivalent | APEX DENTAL MATERIALS, INC. |
| K061906 | CLEARFIL CERAMIC PRIMER | Sep 28, 2006 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K061860 | CLEARFIL MAJESTY ESTHETIC | Sep 18, 2006 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K061664 | FORMCORE DC, MODEL 28-700100 | Sep 08, 2006 | Substantially Equivalent | J. MORITA USA, INC. |
| K060893 | MODIFICATION TO REBILDA DC | May 25, 2006 | Substantially Equivalent | VOCO GMBH |
| K060472 | PREMISE FLOWABLE | Apr 28, 2006 | Substantially Equivalent | KERR CORPORATION |
| K060637 | DENFIL FLOW | Mar 16, 2006 | Substantially Equivalent | VERICOM CO., LTD. |
| K051931 | AXCEL | Feb 17, 2006 | Substantially Equivalent | TRI DENTAL INNOVATORS |
| K053391 | X-TRA FIL | Feb 15, 2006 | Substantially Equivalent | VOCO GMBH |
| K052820 | PARAPOST PARACORE AUTOMIX 5ML | Jan 09, 2006 | Substantially Equivalent | COLTENE/WHALEDENT AG |
| K052779 | BRECOMP | Dec 20, 2005 | Substantially Equivalent | BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT |
| K052106 | SIMILE FLOW | Oct 31, 2005 | Substantially Equivalent | PENTRON CLINICAL TECHNOLOGIES |
| K052097 | CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE | Aug 12, 2005 | Substantially Equivalent | DENTSPLY INTERNATIONAL |
| K051808 | ESTELITE FLOW QUICK | Aug 08, 2005 | Substantially Equivalent | TOKUYAMA DENTAL CORPORATION |
| K051818 | BEAUTIFIL FLOW | Aug 03, 2005 | Substantially Equivalent | SHOFU DENTAL CORP. |
| K051868 | GRANDIO FLOW | Jul 27, 2005 | Substantially Equivalent | VOCO GMBH |
| K051867 | GRANDIO | Jul 27, 2005 | Substantially Equivalent | VOCO GMBH |
| K050401 | CERAMAGE | Apr 28, 2005 | Substantially Equivalent | SHOFU DENTAL CORP. |
| K050880 | DYRACT EXTRA RESTORATIVE | Apr 22, 2005 | Substantially Equivalent | DENTSPLY INTL. |
| K042804 | TESCERA OPAQUER POWDER/SCULPTING RESIN | Feb 01, 2005 | Substantially Equivalent | BISCO, INC. |
| K043177 | CLEAFIL DC CORE AUTOMIX | Dec 17, 2004 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K043119 | AMELOGEN PLUS | Dec 17, 2004 | Substantially Equivalent | ULTRADENT PRODUCTS, INC. |
| K042929 | ESTENIA C&B | Dec 06, 2004 | Substantially Equivalent | KURARAY MEDICAL KURASHIKI PLANT |
| K042348 | GRADIA DIRECT LOFLO | Nov 18, 2004 | Substantially Equivalent | GC AMERICA, INC. |
| K042819 | TETRIC EVOCERAM | Nov 09, 2004 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K042124 | DENFIL | Aug 13, 2004 | Substantially Equivalent | VERICOM CO., LTD. |
| K040465 | LATIT FLOW | Jul 20, 2004 | Substantially Equivalent | AB ARDENT |
| K040994 | COSMEDENT CORE PASTE | Jun 03, 2004 | Substantially Equivalent | COSMEDENT, INC. |
| K040795 | MULTICORE HB; MULTICORE FLOW | May 17, 2004 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K040144 | QUIXX POSTERIOR RESTORATIVE | Apr 01, 2004 | Substantially Equivalent | DENTSPLY INTERNATIONAL |
| K033970 | CLEARFIL PHOTO CORE PLT | Mar 26, 2004 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K033996 | HERMES | Feb 24, 2004 | Substantially Equivalent | 3M ESPE AG DENTAL PRODUCTS |
| K033808 | GRADIA GUM | Feb 02, 2004 | Substantially Equivalent | GC AMERICA, INC. |
| K033773 | CONCEPT HP ADD-ON; CONCEPT HP ENAMEL | Jan 15, 2004 | Substantially Equivalent | IVOCLAR VIVADENT AG |
| K033665 | VENUS FLOW | Dec 30, 2003 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K033267 | EPRICORD | Dec 22, 2003 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K033117 | GRANDIO FLOW | Nov 25, 2003 | Substantially Equivalent | VOCO GMBH |
| K032921 | PREMISE | Nov 13, 2003 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K031341 | STICK FLOW | Oct 29, 2003 | Substantially Equivalent | STICK TECH LTD. |
| K031721 | COMPOSITE RESTORATION MATERIAL | Sep 11, 2003 | Substantially Equivalent | MILTON HODOSH, M.D. |
| K031877 | EMBRACE WET-BOND RESTORATIVE MATERIAL | Aug 01, 2003 | Substantially Equivalent | PULPDENT CORPORATION |
| K030951 | TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P | Jun 06, 2003 | Substantially Equivalent | BISCO, INC. |
| K030915 | GRANDIO | May 30, 2003 | Substantially Equivalent | VOCO GMBH |
| K030914 | REBILDA DC | May 30, 2003 | Substantially Equivalent | VOCO GMBH |
| K030133 | SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE | Apr 29, 2003 | Substantially Equivalent | DENTALEZ GROUP |
| K024094 | 4 SEASONS | Feb 14, 2003 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K023814 | GRADIA DIRECT | Jan 30, 2003 | Substantially Equivalent | GC AMERICA, INC. |
| K023742 | SCULPTURE PLUS NANO-HYBRID COMPOSITE | Jan 17, 2003 | Substantially Equivalent | PENTRON LABORATORY TECHNOLOGIES |
| K022971 | MICROHYBRID 11 | Nov 25, 2002 | Substantially Equivalent | AB ARDENT |
| K022975 | ETCHING 15 | Nov 22, 2002 | Substantially Equivalent | AB ARDENT |
| K022974 | MICROHYBRID 12 | Nov 22, 2002 | Substantially Equivalent | AB ARDENT |
| K022972 | MICROFILL 13 | Nov 22, 2002 | Substantially Equivalent | AB ARDENT |
| K022675 | PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL | Nov 07, 2002 | Substantially Equivalent | PRIME DENTAL MANUFACTURING, INC. |
| K023002 | CLEARFIL AP-X PLT | Oct 25, 2002 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K022999 | CLEARFIL AP-X PLT INTRO KIT | Oct 24, 2002 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K021250 | MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) | Oct 24, 2002 | Substantially Equivalent | HANDPIECE UNLIMITED |
| K022492 | PULPDENT SEMI-GEL ETCH | Oct 11, 2002 | Substantially Equivalent | PULPDENT CORPORATION |
| K022797 | TWINKY STAR | Oct 10, 2002 | Substantially Equivalent | VOCO GMBH |
| K020113 | VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES | May 17, 2002 | Substantially Equivalent | VECTOR RESEARCH & DEVELOPMENT |
| K020760 | STARFLOW HV | May 03, 2002 | Substantially Equivalent | DANVILLE MATERIALS, INC. |
| K020555 | SONATA MICRO HYBRID COMPOSITE | Apr 22, 2002 | Substantially Equivalent | PENTRON LABORATORY TECHNOLOGIES |
| K020432 | PULPDENT GLAZE | Apr 17, 2002 | Substantially Equivalent | PULPDENT CORPORATION |
| K020342 | UNIFIL FLOW | Mar 28, 2002 | Substantially Equivalent | GC AMERICA, INC. |
| K014111 | REBILDA SC | Mar 06, 2002 | Substantially Equivalent | VOCO GMBH |
| K020131 | VENUS UNIVERSAL LIGHT CURING COMPOSITE | Feb 28, 2002 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K013970 | PRIME-DENT HEMA DESENSITIZER | Feb 19, 2002 | Substantially Equivalent | PRIME DENTAL MANUFACTURING, INC. |
| K014144 | EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 | Feb 07, 2002 | Substantially Equivalent | AFP IMAGING CORP. |
| K013929 | HELIOMOLAR HB TRANSLUCENT SHADES | Feb 07, 2002 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K013510 | POINT 4 MODIFIED | Jan 18, 2002 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K013571 | MAGICFIL | Jan 17, 2002 | Substantially Equivalent | DMG USA, INC. |
| K011839 | DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C | Jan 17, 2002 | Substantially Equivalent | DOXA CERTEX AB |
| K013647 | REVOLUTION FORMULA 2 | Jan 16, 2002 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K013529 | POINT 4 TRANSLUCENT MODIFIED | Jan 09, 2002 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K013400 | SYNERGY FLOW | Dec 10, 2001 | Substantially Equivalent | COLTENE/WHALEDENT INC. |
| K012794 | PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT | Nov 05, 2001 | Substantially Equivalent | PRIME DENTAL MANUFACTURING, INC. |
| K013375 | BELLEGLASS HP OPAQUE 2 | Oct 29, 2001 | Substantially Equivalent | KERR DENTAL MATERIALS CENTER |
| K013325 | POINT 4 FLOWABLE 2 | Oct 23, 2001 | Substantially Equivalent | KERR DENTAL MATERIALS CENTER |
| K012529 | ROK | Oct 22, 2001 | Substantially Equivalent | SOUTHERN DENTAL INDUSTRIES, LTD. |
| K012528 | ICE | Oct 22, 2001 | Substantially Equivalent | SOUTHERN DENTAL INDUSTRIES, LTD. |
| K013009 | BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 | Oct 03, 2001 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K013007 | BELLEGLASS HP ENAMEL 2 | Oct 01, 2001 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K012160 | COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 | Sep 27, 2001 | Substantially Equivalent | PREMIER DENTAL PRODUCTS CO. |
| K012740 | CLEARFIL AP-X | Sep 14, 2001 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K012737 | CHROMA ZONE COLOR STAIN | Sep 14, 2001 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K010849 | VERTEX ETCHANT | Sep 14, 2001 | Substantially Equivalent | APEX DENTAL MATERIALS, INC. |
| K012707 | ESTENIA | Sep 13, 2001 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K012705 | CLEARFIL PHOTO CORE | Sep 11, 2001 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K012704 | CLEARFIL ST OPAQUER | Sep 10, 2001 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K012703 | CLEARFIL CORE NEW BOND | Sep 10, 2001 | Substantially Equivalent | KURARAY MEDICAL INC. |
| K012180 | A-WEAR | Sep 05, 2001 | Substantially Equivalent | BISCO, INC. |
| K012321 | POINT 4 FLOWABLE | Aug 27, 2001 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K012307 | LUXACORE/LUXACORE DUAL | Aug 23, 2001 | Substantially Equivalent | DMG USA, INC. |
| K011798 | CORERESTORE 2 | Aug 14, 2001 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K011453 | TOOTH SHADE RESIN MATERIAL | Jul 23, 2001 | Substantially Equivalent | RITE-DENT MANUFACTURING CORP. |
| K011756 | ADMIRA FLOW | Jul 18, 2001 | Substantially Equivalent | VOCO GMBH |
| K011517 | LUTE; CORE | Jul 10, 2001 | Substantially Equivalent | FIRST SCIENTIFIC LIMITED |
| K011492 | IN TEN-S | Jul 05, 2001 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K011295 | RESTORE-PF VIC; RESTORE-PF VLC CAPSULE | Jun 27, 2001 | Substantially Equivalent | FIRST SCIENTIFIC LIMITED |
| K011309 | LUTE VLC; CORE VLC | Jun 22, 2001 | Substantially Equivalent | FIRST SCIENTIFIC LIMITED |
| K011211 | FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW | Jun 18, 2001 | Substantially Equivalent | DMG USA, INC. |
| K010475 | D/C CORE MATERIAL | May 07, 2001 | Substantially Equivalent | PARKELL, INC. |
| K010914 | BEAUTIFIL | Apr 20, 2001 | Substantially Equivalent | SHOFU DENTAL CORP. |
| K010781 | 3M ESPE HAUR | Apr 13, 2001 | Substantially Equivalent | 3M COMPANY |
| K010196 | TOTAL CURE | Apr 05, 2001 | Substantially Equivalent | BISCO, INC. |
| K010250 | TETRIC CERAM HB | Feb 28, 2001 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K010267 | PALFIQUE ESTELITE LV CLEAR | Feb 27, 2001 | Substantially Equivalent | TOKUYAMA AMERICA, INC. |
| K010219 | CHALLENGER DIRECT COMPOSITE | Feb 21, 2001 | Substantially Equivalent | INTERNATIONAL DENTAL RESEARCH |
| K002863 | PALFIQUE ESTELITE LV | Jan 04, 2001 | Substantially Equivalent | TOKUYAMA AMERICA, INC. |
| K003034 | COLTENE AURA COMPOMER RESTORATIVE SYSTEM | Nov 30, 2000 | Substantially Equivalent | COLTENE/WHALEDENT INC. |
| K003361 | RENEW LS-2 | Nov 28, 2000 | Substantially Equivalent | BISCO, INC. |
| K003317 | RENEW LS-1 | Nov 21, 2000 | Substantially Equivalent | BISCO, INC. |
| K001899 | IMPROVED TRY-IN GEL | Aug 28, 2000 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K002086 | PRIMAFLOW | Aug 17, 2000 | Substantially Equivalent | DMG USA, INC. |
| K001799 | DC-TELL | Aug 10, 2000 | Substantially Equivalent | AUSTENAL, INC. |
| K001913 | CLEARFIL ST OPAQUER | Aug 04, 2000 | Substantially Equivalent | KURARAY COMPANY, LTD. |
| K001623 | SCULPTURE FLOW | Jul 11, 2000 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K001518 | GRADIA | Jul 05, 2000 | Substantially Equivalent | GC AMERICA, INC. |
| K001360 | SIGNUM | Jun 20, 2000 | Substantially Equivalent | J.F. JELENKO & CO., INC. |
| K001108 | PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL | May 30, 2000 | Substantially Equivalent | PRIME DENTAL MANUFACTURING, INC. |
| K000530 | BELLEGLASS HP ENAMEL | May 17, 2000 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K000357 | EZ CONNECT RESIN | Apr 28, 2000 | Substantially Equivalent | KERR DENTAL MATERIALS CENTER |
| K000436 | BELLEGLASS HP TRANSLUCENT DENTIN | Mar 24, 2000 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K000269 | BELLEGLASS HP OPACEOUS DENTIN | Mar 23, 2000 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K000211 | BUILD-IT FR | Mar 17, 2000 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K993514 | DEFINITE | Feb 24, 2000 | Substantially Equivalent | DEGUSSA - NEY DENTAL, INC. |
| K994304 | ARABESK FLOW | Feb 07, 2000 | Substantially Equivalent | VOCO GMBH |
| K994268 | ARABESK TOP | Feb 03, 2000 | Substantially Equivalent | VOCO GMBH |
| K994224 | PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL | Jan 31, 2000 | Substantially Equivalent | PRIME DENTAL MANUFACTURING, INC. |
| K993659 | RENAMEL PACK | Jan 18, 2000 | Substantially Equivalent | COSMEDENT, INC. |
| K993658 | RENAMEL SCULPT | Jan 18, 2000 | Substantially Equivalent | COSMEDENT, INC. |
| K994056 | ADMIRA | Jan 12, 2000 | Substantially Equivalent | VOCO GMBH |
| K993973 | FUJI II LC CAPSULE | Jan 11, 2000 | Substantially Equivalent | GC AMERICA, INC. |
| K994251 | KETAC-MOLAR QUICK | Jan 03, 2000 | Substantially Equivalent | ESPE DENTAL AG |
| K993932 | SOLITAIRE 2 | Dec 22, 1999 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K993716 | PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE | Dec 21, 1999 | Substantially Equivalent | HARRY J. BOSWORTH CO. |
| K993602 | PRE-VISION FILL | Dec 15, 1999 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K993783 | TETRIC FLOW | Dec 13, 1999 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K993566 | PROMPTFLOW | Dec 06, 1999 | Substantially Equivalent | ESPE DENTAL AG |
| K992909 | HYTAC | Nov 24, 1999 | Substantially Equivalent | ESPE DENTAL AG |
| K993488 | LIGHT-CORE | Nov 10, 1999 | Substantially Equivalent | BISCO, INC. |
| K993192 | ILLUSION | Oct 27, 1999 | Substantially Equivalent | BISCO, INC. |
| K992966 | REFERENCE | Oct 07, 1999 | Substantially Equivalent | ESPE DENTAL AG |
| K992645 | SINFONY | Sep 22, 1999 | Substantially Equivalent | ESPE DENTAL AG |
| K992102 | LUMA LIGHT 2000 CURE LIGHT | Aug 31, 1999 | Substantially Equivalent | LUMA LITE, INC, |
| K992248 | POST CEMENT HI-X | Aug 25, 1999 | Substantially Equivalent | BISCO, INC. |
| K992118 | PRODIGY 4 TRANSLUCENT SHADES | Aug 18, 1999 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K991961 | 3M LVR SYSTEM | Aug 09, 1999 | Substantially Equivalent | 3M COMPANY |
| K991450 | ETCHING GEL | Jul 09, 1999 | Substantially Equivalent | SILICON-UND COMPOSITE SPEZIALITATEN GMBH |
| K991491 | FLC COMPOSITE | Jun 21, 1999 | Substantially Equivalent | HARRY J. BOSWORTH CO. |
| K991488 | SELF CURE COMPOSITE | Jun 21, 1999 | Substantially Equivalent | HARRY J. BOSWORTH CO. |
| K991442 | LC MICROFILL | Jun 03, 1999 | Substantially Equivalent | S & C POLYMER GMBH |
| K990756 | FLOW LINE | May 07, 1999 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K990982 | CAVIT LC | Apr 23, 1999 | Substantially Equivalent | ESPE DENTAL AG |
| K990898 | PRODIGY 4 | Apr 06, 1999 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K990314 | MULTI-CURE COMPOSITE CEMENT | Apr 02, 1999 | Substantially Equivalent | MEDENTAL INTL. |
| K990108 | LC FLOWFILL | Mar 09, 1999 | Substantially Equivalent | S & C POLYMER GMBH |
| K990315 | MONOPAQUE | Mar 04, 1999 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K984097 | DC-CORE | Feb 09, 1999 | Substantially Equivalent | S & C POLYMER GMBH |
| K984484 | LC MICROHYBRID | Jan 20, 1999 | Substantially Equivalent | S & C POLYMER GMBH |
| K984387 | R-30 AESTHETIC RESTORATIVE | Jan 13, 1999 | Substantially Equivalent | DENTSPLY INTL. |
| K984112 | ADVENT | Dec 22, 1998 | Substantially Equivalent | BISCO, INC. |
| K984044 | QUADRANT POSTERIOR DENSE | Dec 16, 1998 | Substantially Equivalent | CAVEX HOLLAND B.V. |
| K984043 | QUADRANT TOTAL ETCH | Dec 04, 1998 | Substantially Equivalent | CAVEX HOLLAND B.V. |
| K984042 | QUADRANT CORE LC | Dec 04, 1998 | Substantially Equivalent | CAVEX HOLLAND B.V. |
| K984041 | QUADRANT UNIVERSAL LC | Dec 04, 1998 | Substantially Equivalent | CAVEX HOLLAND B.V. |
| K983751 | QUADRANT UNICHEM | Nov 30, 1998 | Substantially Equivalent | CAVEX HOLLAND B.V. |
| K983549 | QUADRANT ANTERIOR SHINE | Nov 23, 1998 | Substantially Equivalent | CAVEX HOLLAND B.V. |
| K983370 | PRODIGY- 3 | Nov 18, 1998 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K980800 | LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL | Nov 09, 1998 | Substantially Equivalent | COSMEDENT, INC. |
| K983091 | ELAN-2 | Oct 28, 1998 | Substantially Equivalent | KERR DENTAL MATERIALS CENTER |
| K982692 | STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC | Oct 22, 1998 | Substantially Equivalent | STERNGOLD/IMPLAMED |
| K982259 | CHROMA ZONE COLOR STAIN | Sep 22, 1998 | Substantially Equivalent | KURARAY AMERICA, INC. |
| K982729 | RENEW | Sep 15, 1998 | Substantially Equivalent | BISCO, INC. |
| K982318 | SPECTRUM 800 CURING UNIT | Sep 15, 1998 | Substantially Equivalent | DENTSPLY INTL. |
| K982191 | CHEMICAL CURE COMPOSITE WITH ENAMEL BOND | Sep 14, 1998 | Substantially Equivalent | MEDENTAL INTL. |
| K982645 | PYRAMID | Sep 02, 1998 | Substantially Equivalent | BISCO, INC. |
| K982395 | DYTRACT FLOW RESTORATIVE | Aug 18, 1998 | Substantially Equivalent | DENTSPLY INTL. |
| K981948 | APOLLO 95E | Aug 18, 1998 | Substantially Equivalent | DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. |
| K982201 | ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) | Aug 10, 1998 | Substantially Equivalent | FOREMOST DENTAL MFG., INC. |
| K982164 | ESTENIA | Aug 10, 1998 | Substantially Equivalent | KURARAY AMERICA, INC. |
| K981647 | 3M DENT II SYSTEM | Aug 09, 1998 | Substantially Equivalent | 3M COMPANY |
| K982148 | PRODIGY 2 | Jul 31, 1998 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K981562 | SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT | Jul 30, 1998 | Substantially Equivalent | SULZER CALCITEK, INC. |
| K981813 | PERMACEM AUTOMIX LUTING CEMENT SYSTEM | Jul 10, 1998 | Substantially Equivalent | FOREMOST DENTAL MFG., INC. |
| K981264 | ARISTON PHC | Jul 02, 1998 | Substantially Equivalent | IVOCLAR USA, INC. |
| K980018 | CRISTOBAL | May 19, 1998 | Substantially Equivalent | NEWAVE MEDICAL, INC. |
| K980793 | Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT | May 15, 1998 | Substantially Equivalent | ROLENCE ENTERPRISE CO. LTD. |
| K980792 | CU-100A LIGHT CURE UNIT | May 15, 1998 | Substantially Equivalent | ROLENCE ENTERPRISE CO. LTD. |
| K980058 | TOKUSO MAC BOND II | Apr 27, 1998 | Substantially Equivalent | TOKUYAMA AMERICA, INC. |
| K980054 | PALFIQUE ESTELITE | Apr 27, 1998 | Substantially Equivalent | TOKUYAMA AMERICA, INC. |
| K974465 | SYNERGY | Mar 09, 1998 | Substantially Equivalent | COLTENE/WHALEDENT INC. |
| K980051 | PALFIQUE ESTELITE PASTE | Feb 24, 1998 | Substantially Equivalent | TOKUYAMA AMERICA, INC. |
| K974483 | NTL-FLOW | Feb 09, 1998 | Substantially Equivalent | BISCO, INC. |
| K973221 | COMPOSITE 168 RESTORATIVE SYSTEM | Feb 09, 1998 | Substantially Equivalent | DENTSPLY INTL. |
| K973235 | DYRACT AP RESTORATIVE | Feb 05, 1998 | Substantially Equivalent | DENTSPLY INTL. |
| K974413 | PERMAFLO | Feb 02, 1998 | Substantially Equivalent | ULTRADENT PRODUCTS, INC. |
| K974577 | COMPOGLASS FLOW | Jan 30, 1998 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K974282 | VITALESCENCE | Jan 29, 1998 | Substantially Equivalent | ULTRADENT PRODUCTS, INC. |
| K974105 | KERR COMPOMER | Jan 09, 1998 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K973513 | SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER | Dec 22, 1997 | Substantially Equivalent | ESPE GMBH & CO. KG. |
| K974131 | ALERT | Dec 17, 1997 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K973091 | WAVE | Dec 08, 1997 | Substantially Equivalent | SOUTHERN DENTAL INDUSTRIES, INC. |
| K973089 | FREEDOM | Dec 08, 1997 | Substantially Equivalent | SOUTHERN DENTAL INDUSTRIES, INC. |
| K973976 | EPIC-FLO | Dec 04, 1997 | Substantially Equivalent | PARKELL, INC. |
| K973257 | VERSAETCH | Nov 17, 1997 | Substantially Equivalent | CENTRIX, INC. |
| K972292 | SOLIDEX | Oct 29, 1997 | Substantially Equivalent | SHOFU DENTAL CORP. |
| K972892 | CAVIT-LC | Oct 02, 1997 | Substantially Equivalent | ESPE GMBH & CO. KG. |
| K971762 | BELLEGLASS HP ENAMEL REPAIR MATERIAL | Sep 12, 1997 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K971594 | FLOW-RITE | Sep 12, 1997 | Substantially Equivalent | PULPDENT CORP. |
| K970683 | ZENTIH FLOWABLE COMPOSITE (MULTIPLE) | Jul 15, 1997 | Substantially Equivalent | FOREMOST DENTAL MFG., INC. |
| K971898 | PERMALUTE, TRY-IN PASTE | Jun 24, 1997 | Substantially Equivalent | ULTRADENT PRODUCTS, INC. |
| K971513 | COMPOGLASS F | Jun 03, 1997 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K971372 | VARIOLINK II | May 29, 1997 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K970500 | 3M SUSTEL DENTAL SYSTEM | Apr 30, 1997 | Substantially Equivalent | 3M COMPANY |
| K970495 | FOUNDATION INDIRECT COMPOSITE RESIN | Apr 16, 1997 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K970246 | EDTA CAVIT | Apr 16, 1997 | Substantially Equivalent | KAROLINSKI |
| K962376 | KREATIV KURING LIGHT SYSTEM | Mar 21, 1997 | Substantially Equivalent | KREATIV, INC. |
| K964931 | WHITE CORE | Feb 10, 1997 | Substantially Equivalent | BISCO, INC. |
| K965060 | ULTRA-ETCH STAT | Jan 31, 1997 | Substantially Equivalent | ULTRADENT PRODUCTS, INC. |
| K964285 | TETRIC CERAM | Jan 22, 1997 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K964179 | SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS | Jan 09, 1997 | Substantially Equivalent | S.S. WHITE MFG., LTD. |
| K964578 | FIBREKOR | Dec 03, 1996 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K963805 | PRODIGY AC | Nov 27, 1996 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K963735 | COJET SYSTEM | Nov 27, 1996 | Substantially Equivalent | ESPE GMBH & CO. KG. |
| K963652 | PULPDENT DESENSITIZER | Oct 11, 1996 | Substantially Equivalent | PULPDENT CORP. |
| K963311 | TEAM ETCH | Oct 07, 1996 | Substantially Equivalent | CENTRIX, INC. |
| K962909 | DENTAL PREP WASH AND PREP DISINFECT | Oct 07, 1996 | Substantially Equivalent | WILLIAM J. DAY |
| K962878 | TARGIS SYSTEM | Sep 25, 1996 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K962442 | HYTAC APLITIP/HYTAC OSB | Sep 11, 1996 | Substantially Equivalent | ESPE GMBH & CO. KG. |
| K962440 | PERTAC II/PERTAC II APLITIP | Sep 11, 1996 | Substantially Equivalent | ESPE GMBH & CO. KG. |
| K962192 | SUNRISE CURING LAMP | Sep 03, 1996 | Substantially Equivalent | SUNRISE TECHNOLOGIES, INC. |
| K962405 | SANICURE DISPOSABLE CURING PROBE | Aug 29, 1996 | Substantially Equivalent | EFOS CANADA, INC. |
| K961434 | VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM | Jul 08, 1996 | Substantially Equivalent | VIDENT |
| K960667 | CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE | Jul 02, 1996 | Substantially Equivalent | WALLACE A. ERICKSON & CO. |
| K961284 | KOLOR + | May 08, 1996 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K960729 | ENAMEL CONDITIONER (ENAMEL ETCHING AGENT) | Apr 26, 1996 | Substantially Equivalent | DENT ZAR, INC. |
| K960600 | LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS | Apr 26, 1996 | Substantially Equivalent | DENT ZAR, INC. |
| K960599 | SUPERIOR PHOTOCURING HYBRID COMPOSITE | Apr 26, 1996 | Substantially Equivalent | DENT ZAR, INC. |
| K960598 | CONCORD MARYLAND BRIDGE CEMENT | Apr 26, 1996 | Substantially Equivalent | DENT ZAR, INC. |
| K960597 | ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CURE | Apr 26, 1996 | Substantially Equivalent | DENT ZAR, INC. |
| K960596 | ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE | Apr 26, 1996 | Substantially Equivalent | DENT ZAR, INC. |
| K960595 | FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS | Apr 26, 1996 | Substantially Equivalent | DENT ZAR, INC. |
| K960594 | LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETS | Apr 26, 1996 | Substantially Equivalent | DENT ZAR, INC. |
| K960565 | ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE | Mar 22, 1996 | Substantially Equivalent | DENT ZAR, INC. |
| K960165 | ALPHA-DENT COMPOSITE SURFACE SEALANT | Mar 15, 1996 | Substantially Equivalent | WALLACE A. ERICKSON & CO. |
| K954988 | CRYSTALLESSENCE | Mar 08, 1996 | Substantially Equivalent | CONFI-DENTAL PRODUCTS CO. |
| K955337 | OPAKER | Jan 23, 1996 | Substantially Equivalent | KERR DENTAL MATERIALS CENTER |
| K955292 | AELITEFLO | Dec 13, 1995 | Substantially Equivalent | BISCO, INC. |
| K954929 | CHARISMA SINGLE DOSE | Nov 27, 1995 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K954408 | AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE BUILDUP BLUE PASTEE | Oct 30, 1995 | Substantially Equivalent | AMERICAN DENTAL PRODUCTS, INC. |
| K954407 | AMERICAN DENTAL PRODUCTS WHITE COMPOSITE RESIN CORE PASTE WITH FLUORIDE | Oct 30, 1995 | Substantially Equivalent | AMERICAN DENTAL PRODUCTS, INC. |
| K954406 | AMERICAN DENTAL PRODUCTS COMPOSITE RESIN CORE PASTE WITH FLUORIDE | Oct 30, 1995 | Substantially Equivalent | AMERICAN DENTAL PRODUCTS, INC. |
| K954405 | AMERICAN DENTAL PRODDUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE PASTE WITH FLUORIDE | Oct 30, 1995 | Substantially Equivalent | AMERICAN DENTAL PRODUCTS, INC. |
| K954461 | AMERICAN DENTAL PRODUCTS CORE BUILDUP PASTE | Oct 16, 1995 | Substantially Equivalent | AMERICAN DENTAL PRODUCTS, INC. |
| K954115 | ARTGLASS & KEVLOC | Sep 27, 1995 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K953525 | ULTRADENT FLOWABLE COMPOSITE | Aug 28, 1995 | Substantially Equivalent | ULTRADENT PRODUCTS, INC. |
| K952662 | COMP=FLOW | Aug 28, 1995 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K952353 | EZ-COMP | Aug 10, 1995 | Substantially Equivalent | ADM, INC. |
| K952333 | PLASMA ARC CURING SYSTEM | Aug 10, 1995 | Substantially Equivalent | AMERICAN DENTAL TECHNOLOGIES, INC. |
| K952500 | COMPSEAL | Jun 22, 1995 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K951836 | COMPOLGLASS COMPOGLASS SCA | May 25, 1995 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K951427 | AMERICAN DENTAL PRODUCTS (ADP), COMPOSITE RESTORATIVE MATERIAL | May 15, 1995 | Substantially Equivalent | AMERICAN DENTAL PRODUCTS, INC. |
| K951426 | AMERICAN DENTAL PRODUCTS (ADP), VISIBLE LIGHT CURE COMPOSITE DENTAL RESTORATIVE MATERIAL | May 12, 1995 | Substantially Equivalent | AMERICAN DENTAL PRODUCTS, INC. |
| K950991 | DYRACT II RESTORATIVE | Mar 23, 1995 | Substantially Equivalent | DENTSPLY INTL. |
| K950859 | PERMASEAL | Mar 23, 1995 | Substantially Equivalent | ULTRADENT PRODUCTS, INC. |
| K950765 | COMPA LAB-R | Mar 13, 1995 | Substantially Equivalent | ROBERT W. BAUER & ASSOC., INC. |
| K942993 | THERMORESIN LC II | Feb 07, 1995 | Substantially Equivalent | GC AMERICA, INC. |
| K946307 | CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE | Jan 26, 1995 | Substantially Equivalent | CONFI-DENTAL PRODUCTS CO. |
| K945769 | TOTAL ETCH GEL | Dec 29, 1994 | Substantially Equivalent | DENTSPLY INTL. |
| K945539 | OPTIGUARD | Dec 29, 1994 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K945364 | DYRACT(TM) MATERIAL | Dec 29, 1994 | Substantially Equivalent | DENSTPLY DETREY-DEDENT |
| K945173 | PULPDENT HARDSHELL | Dec 15, 1994 | Substantially Equivalent | PULPDENT CORP. |
| K945113 | PULPDENT CERVICAL RESTORATIVE | Dec 14, 1994 | Substantially Equivalent | PULPDENT CORP. |
| K945058 | PULPDENT MICROFILLED ANTERIOR COMPOSITE | Dec 14, 1994 | Substantially Equivalent | PULPDENT CORP. |
| K945057 | PULPDENT HYBRID ANTERIOR COMPOSITE | Dec 14, 1994 | Substantially Equivalent | PULPDENT CORP. |
| K945056 | PULPDENT RESIN CEMENT | Dec 14, 1994 | Substantially Equivalent | PULPDENT CORP. |
| K945018 | PULPDENT HARD DENTAL POSTERIOR FILLING MATERIAL | Dec 14, 1994 | Substantially Equivalent | PULPDENT CORP. |
| K944659 | PRODIGY | Dec 08, 1994 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K943642 | HERCULITE XR & XRV | Nov 17, 1994 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K943169 | CLEARFIL AP-X AND LINER BOND 2 | Aug 10, 1994 | Substantially Equivalent | KURARAY COMPANY, LTD. |
| K943168 | CLEARFIL AP-X | Aug 10, 1994 | Substantially Equivalent | KURARAY COMPANY, LTD. |
| K942767 | ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN | Jul 08, 1994 | Substantially Equivalent | WALLACE A. ERICKSON & CO. |
| K941899 | SDI COMPOSTIES | Jul 05, 1994 | Substantially Equivalent | SOUTHERN DENTAL INDUSTRIES, INC. |
| K942031 | CAULK TOOTH CONDITIONER GEL AND SYRINGE | Jun 10, 1994 | Substantially Equivalent | DENTSPLY INTL. |
| K940737 | EDTA GEL (TM) | Jun 03, 1994 | Substantially Equivalent | KAROLINSKA INSTITUTET |
| K941377 | CONQUEST SMOOTH TOUCH | May 03, 1994 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K941373 | PENT CORE PLUS (PASTE-PASTE) | May 03, 1994 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K941378 | PROCOM | May 02, 1994 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K941376 | CONQUEST SENIOR | May 02, 1994 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K941375 | CONQUEST GINGA-BLEND | May 02, 1994 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K941374 | CONQUEST PRELUDE | May 02, 1994 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K940800 | DENTACOLOR VITA (VS) SHADE SYSTEM | Apr 07, 1994 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K930584 | MAGNACORE | Feb 22, 1994 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K930583 | MEGABOND SYSTEM | Feb 22, 1994 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K932828 | CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE | Feb 03, 1994 | Substantially Equivalent | ALPHA-DENT |
| K932829 | CENTRIX'S ENCORE NATURAL COMPOSITE RESIN CORE PAST | Jan 28, 1994 | Substantially Equivalent | ALPHA-DENT |
| K932826 | CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUO | Jan 28, 1994 | Substantially Equivalent | ALPHA-DENT |
| K935736 | CHARISMA SUPERLIGHT | Jan 26, 1994 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K933766 | HIGH-Q-BOND | Jan 26, 1994 | Substantially Equivalent | SILMET U.S.A. CORP. |
| K922252 | TI-CORE NEW & IMPROVED | Jan 26, 1994 | Substantially Equivalent | ESSENTIAL DENTAL SYSTEMS, INC. |
| K922251 | TI-CORE-NATURAL | Jan 26, 1994 | Substantially Equivalent | ESSENTIAL DENTAL SYSTEMS, INC. |
| K935032 | ZENITH TOTAL ETCH 10% PHOSPHORIC ACID | Jan 18, 1994 | Substantially Equivalent | FOREMOST DENTAL MFG., INC. |
| K934247 | BISCO UNIVERSAL HYBRID COMPOSITE | Nov 29, 1993 | Substantially Equivalent | BISCO, INC. |
| K934611 | STO2P | Nov 17, 1993 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K933656 | JEDENTAL PSROFILL SELF-CURE COMPOSITE | Nov 17, 1993 | Substantially Equivalent | JEDENTAL CO., INC. |
| K930128 | SR SPECTRASIT, SR CHROMASIT | Oct 07, 1993 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K932886 | ALPHA-DENT LIGHT ACTIVATED CORE BUILDUP BLUE PASTE | Sep 29, 1993 | Substantially Equivalent | WALLACE A. ERICKSON & CO. |
| K932827 | ALPHA-DENT CORE BUILDUP PASTE | Sep 23, 1993 | Substantially Equivalent | ALPHA-DENT |
| K932154 | CONQUEST CRYSTAL | Sep 15, 1993 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K932793 | PULPDENT 2.5% NITRIC ACID ETCHANT | Sep 13, 1993 | Substantially Equivalent | PULPDENT CORP. |
| K932227 | AMELOGEN RESTORATIVE MATERIALS | Sep 13, 1993 | Substantially Equivalent | ULTRADENT PRODUCTS, INC. |
| K932792 | PULPDENT MALEIC ACID ETCHANTS | Sep 09, 1993 | Substantially Equivalent | PULPDENT CORP. |
| K931867 | ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE | Sep 09, 1993 | Substantially Equivalent | ULTRADENT PRODUCTS, INC. |
| K932395 | VLC DR MATERIAL | Aug 25, 1993 | Substantially Equivalent | DENTSPLY INTL. |
| K930405 | BISCO D/C CORE COMPOSITE | Aug 24, 1993 | Substantially Equivalent | BISCO, INC. |
| K931309 | VARIOLINK | Jul 22, 1993 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K932013 | CHARISMA -- MODIFIED | Jul 08, 1993 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K931880 | PROFILL LC COMPOSITE | Jul 08, 1993 | Substantially Equivalent | JEDENTAL CO., INC. |
| K924727 | 100 LIGHT CURE UNIT | Jun 17, 1993 | Substantially Equivalent | ROLENCE ENTERPRISE CO. LTD. |
| K920533 | DENTIN BONDING AGENT | May 19, 1993 | Substantially Equivalent | CONFI-DENTAL PRODUCTS CO. |
| K926556 | VIVALUX | Apr 23, 1993 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K926418 | CLIP | Mar 31, 1993 | Substantially Equivalent | VOCO GMBH |
| K926074 | PULPDENT DENTAL BOND ENCHANCER | Mar 16, 1993 | Substantially Equivalent | PULPDENT CORP. |
| K925162 | MICRODOSE DENTIN CONDITIONER | Mar 16, 1993 | Substantially Equivalent | UNICEP |
| K924826 | MICRODOSE TOTAL ETCHANT | Mar 05, 1993 | Substantially Equivalent | UNICEP |
| K924822 | MICRODOSE ENAMEL ETCHANT | Mar 05, 1993 | Substantially Equivalent | UNICEP |
| K925383 | PHOTO CLEARFIL OPAQUER | Jan 28, 1993 | Substantially Equivalent | KURARAY CO. |
| K924151 | BISCO D/C RESINOMER | Dec 28, 1992 | Substantially Equivalent | BISCO, INC. |
| K923472 | COMPACOLOR | Oct 13, 1992 | Substantially Equivalent | WILDE-USA, INC. |
| K923867 | METAFIL | Oct 06, 1992 | Substantially Equivalent | PARKELL |
| K923236 | TRIAD INLAY COMPOSITE | Sep 11, 1992 | Substantially Equivalent | DENTSPLY INTL. |
| K921602 | ULTRADENT PRODUCT TOOTH SURFACE DRYING AGENT | Sep 09, 1992 | Substantially Equivalent | ULTRADENT PRODUCTS, INC. |
| K921598 | ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE | Sep 09, 1992 | Substantially Equivalent | ULTRADENT PRODUCTS, INC. |
| K921409 | ENAMEL AND PORCELAIN ETCH PRODUCT LINE | Sep 09, 1992 | Substantially Equivalent | ULTRADENT PRODUCTS, INC. |
| K921407 | COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE | Sep 09, 1992 | Substantially Equivalent | ULTRADENT PRODUCTS, INC. |
| K921174 | COMPOSITE RESIN CORE PASTE MATERIAL | Sep 01, 1992 | Substantially Equivalent | CENTRIX, INC. |
| K920893 | LITE FILL II P | Sep 01, 1992 | Substantially Equivalent | SHOFU DENTAL CORP. |
| K920892 | LITE FIL II A | Sep 01, 1992 | Substantially Equivalent | SHOFU DENTAL CORP. |
| K922755 | PULPDENT HARD CORE | Aug 20, 1992 | Substantially Equivalent | PULPDENT CORP. |
| K922569 | TETRIC LIGHT-CURING COMPOSITE | Jul 15, 1992 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K921820 | RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION | Jun 16, 1992 | Substantially Equivalent | COSMEDENT, INC. |
| K921439 | BISCO CORE PASTE | May 11, 1992 | Substantially Equivalent | BISCO, INC. |
| K920485 | PUPLDENT ETCH N PREP | Apr 29, 1992 | Substantially Equivalent | PULPDENT CORP. |
| K920483 | 10% PHOSPHORIC ACID ETCHING GEL | Apr 29, 1992 | Substantially Equivalent | PULPDENT CORP. |
| K920484 | 2.5% NITRIC ACID ETCHING GEL | Apr 28, 1992 | Substantially Equivalent | PULPDENT CORP. |
| K920482 | 14% HYDROFLUORIC ACID ETCHING GEL | Apr 28, 1992 | Substantially Equivalent | PULPDENT CORP. |
| K915668 | BISCO CAVITY CLEANSER | Apr 21, 1992 | Substantially Equivalent | BISCO, INC. |
| K913089 | WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS | Apr 21, 1992 | Substantially Equivalent | WILDE-USA, INC. |
| K920425 | 3M BRAND RESTORATIVE Z100 | Mar 20, 1992 | Substantially Equivalent | 3M COMPANY |
| K920365 | TOOTH BONDING AGENT | Mar 19, 1992 | Substantially Equivalent | VOCO GMBH |
| K914456 | DENTACOLOR(R) CRE-ACTIVE | Mar 11, 1992 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K915336 | TWINLOOK | Feb 03, 1992 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K913200 | GTI CLASP COVER | Feb 03, 1992 | Substantially Equivalent | GTI, INC. |
| K915355 | ADS-GEL AND INSULATING-GEL | Jan 31, 1992 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K915335 | SILICOATER SYSTEM | Jan 21, 1992 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K913966 | SONO(R) -CEM | Jan 14, 1992 | Substantially Equivalent | ESPE GMBH (US) |
| K913947 | IMPERVA BOND | Oct 09, 1991 | Substantially Equivalent | SHOFU DENTAL CORP. |
| K913100 | PALFIQUE INLAY | Oct 02, 1991 | Substantially Equivalent | TOKUYAMA AMERICA, INC. |
| K913099 | PALFIQUE LITEPOSTERIOR | Oct 02, 1991 | Substantially Equivalent | TOKUYAMA AMERICA, INC. |
| K912788 | CURAY SUPPORT | Aug 23, 1991 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K912708 | CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM | Aug 20, 1991 | Substantially Equivalent | KURARAY CO. |
| K912037 | DEGULUX LIGHT CURING UNIT | Jun 07, 1991 | Substantially Equivalent | DEGUSSA AG |
| K910263 | CHARISMA | Jun 03, 1991 | Substantially Equivalent | KULZER, INC. |
| K904813 | VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT. | May 31, 1991 | Substantially Equivalent | ALPHA-DENT |
| K911524 | PALFIQUE ESTELITE | May 29, 1991 | Substantially Equivalent | TOKUYAMA AMERICA, INC. |
| K910627 | ALPHA-FIL, ALPHA-BASE & ALPHA-SILVER, MODIFICATION | May 29, 1991 | Substantially Equivalent | FOREMOST MFG., INC. |
| K905604 | VISIO-GEM ART-SYSTEM | Mar 29, 1991 | Substantially Equivalent | ESPE GMBH (US) |
| K904805 | TENTATIVE OPERATING NAME-JAZZ BAND | Mar 29, 1991 | Substantially Equivalent | FRANKLIN M. DIN D.M.D., P.A. |
| K905131 | DURAFILL COLOR VS | Mar 15, 1991 | Substantially Equivalent | KULZER, INC. |
| K904812 | COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE | Feb 26, 1991 | Substantially Equivalent | ALPHA-DENT |
| K905476 | STOMADENT TM | Feb 20, 1991 | Substantially Equivalent | DENTSPLY INTL. |
| K905221 | SPECIAL BOND II | Dec 17, 1990 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K905220 | MONOBOND S | Dec 17, 1990 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K903481 | ALPHA-FILL, ALPHA-CEM, AND ALPHA-SILVER | Dec 17, 1990 | Substantially Equivalent | DENTAL FOREMOST |
| K904555 | DURAFILL FLOW | Nov 13, 1990 | Substantially Equivalent | KULZER, INC. |
| K901260 | CORADENT | Oct 22, 1990 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K903587 | HELIOLINK TRY-IN PASTES | Oct 09, 1990 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K902040 | ALTIS (RESIN, CROWN AND BRIDGES) | Oct 09, 1990 | Substantially Equivalent | PB2 INVESTMENT, INC. |
| K903551 | TEMPOREX | Oct 05, 1990 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K902893 | TI-CORE (DENTAL COMPOSITE) | Sep 06, 1990 | Substantially Equivalent | MEDICAL DEVICE INSPECTION CO., INC. |
| K902402 | HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE | Aug 29, 1990 | Substantially Equivalent | DENTALEZ GROUP |
| K901869 | DEGUFILL (R) H | Aug 14, 1990 | Substantially Equivalent | DEGUSSA AG |
| K901868 | DEGUFILL (R) M | Aug 14, 1990 | Substantially Equivalent | DEGUSSA AG |
| K902745 | DEGUFILL (TM) | Aug 13, 1990 | Substantially Equivalent | DEGUSSA AG |
| K900510 | PERTAC-HYBRID | Aug 09, 1990 | Substantially Equivalent | ESPE GMBH (US) |
| K902743 | DEGUFILL (TM) ETCHANT GEL | Aug 01, 1990 | Substantially Equivalent | DEGUSSA AG |
| K901872 | DEGUFILL (R) ETCHANT | Aug 01, 1990 | Substantially Equivalent | DEGUSSA AG |
| K901917 | DUAL CEMENT | Jun 28, 1990 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K901914 | HELIO PROGRESS (DENTAL COMPOSITE) | Jun 28, 1990 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K901918 | HELIOTINT | Jun 26, 1990 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K901910 | HELIO LINK (RESIN CEMENT) | Jun 26, 1990 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K901916 | SPECIAL BOND | Jun 22, 1990 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K901697 | SILISTOR CERAMIC AND RESIN REPAIR SYSTEM | Jun 15, 1990 | Substantially Equivalent | KULZER, INC. |
| K896469 | EOS INLAY MATERIAL | May 25, 1990 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K901396 | CONCEPT INLAY/ONLAY | May 15, 1990 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K897011 | PALFIQUE LIGHT-S COMPOSITE RESIN | May 15, 1990 | Substantially Equivalent | TOKUYAMA AMERICA, INC. |
| K897010 | PALFIQUE LIGHT COMPOSITE RESIN | May 15, 1990 | Substantially Equivalent | TOKUYAMA AMERICA, INC. |
| K896769 | INTERFACE BONDING SYSTEM | May 15, 1990 | Substantially Equivalent | SMILE HORIZONS, INC. |
| K896530 | FERMIT TEMPORARY MATERIAL | May 07, 1990 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K901051 | 22% POLYACRYLIC ACID GEL | Apr 30, 1990 | Substantially Equivalent | PULPDENT CORP. |
| K900690 | CLEARFIL VENEER BOND KIT | Apr 13, 1990 | Substantially Equivalent | KURARAY CO. |
| K896950 | CORE BUILD UP COMPOSITE | Mar 13, 1990 | Substantially Equivalent | CONFI-DENTAL PRODUCTS CO. |
| K896662 | AIR BLOCK | Feb 14, 1990 | Substantially Equivalent | PULPDENT CORP. |
| K896658 | DENTIN DISCLOSING GEL AND GEL REMOVER | Feb 14, 1990 | Substantially Equivalent | PULPDENT CORP. |
| K896654 | DRYING AGENT | Feb 14, 1990 | Substantially Equivalent | PULPDENT CORP. |
| K896653 | SEPARATING MEDIUM (POLYVINYL ALCOHOL) | Feb 14, 1990 | Substantially Equivalent | PULPDENT CORP. |
| K896564 | DENTAL CORE MATERIAL | Feb 09, 1990 | Substantially Equivalent | DENTSPLY INTL. |
| K896132 | ENAMEL PREP ENAMEL ETCHANT (EMAIL-PREPARATOR GS) | Jan 10, 1990 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K895976 | TOOTH SHADE RESIN | Dec 22, 1989 | Substantially Equivalent | G-C INTL. CORP. |
| K895401 | NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM | Dec 04, 1989 | Substantially Equivalent | ROCKY MOUNTAIN ORTHODONTICS, INC. |
| K894890 | CRYSTALLINE C2 AND CRYSTALLINE L3 | Oct 27, 1989 | Substantially Equivalent | CONFI-DENTAL PRODUCTS CO. |
| K894644 | CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST | Oct 20, 1989 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K892455 | KULZER ADHESIVE CEMENT | Jun 22, 1989 | Substantially Equivalent | KULZER, INC. |
| K892454 | KULZER INLAY SYSTEM | Jun 16, 1989 | Substantially Equivalent | KULZER, INC. |
| K891698 | ZAROLAN, DUALAN, TITAN AND SUPERON | Jun 09, 1989 | Substantially Equivalent | DENT ZAR, INC. |
| K891020 | ESPE TULUX-CEM | May 26, 1989 | Substantially Equivalent | ESPE GMBH (US) |
| K891463 | ADHERENCE M5 MULTI-CURE COMPOSITE CEMENT SYSTEM | May 19, 1989 | Substantially Equivalent | CONFI-DENTAL PRODUCTS CO. |
| K890123 | CLEARFIL CR INLAY | Mar 31, 1989 | Substantially Equivalent | KURARAY CO. |
| K890140 | PHOSPHORIC-ACID ETCHING GEL | Mar 29, 1989 | Substantially Equivalent | CENTRIX, INC. |
| K884588 | HELIOMOLAR(R) DENTAL RESTORATIVE | Jan 27, 1989 | Substantially Equivalent | WILLIAMS DENTAL CO., INC. |
| K884681 | UNIREST LC PAINT-ON RESTORATIVE & VENEER CEMENT | Jan 03, 1989 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K884391 | PREMET, METAL PRIMER | Jan 03, 1989 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K884350 | UNIREST COMPOSITE RESTORATIVE, SELF CURED | Jan 03, 1989 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K884351 | UNIREST PL, ANTE./POST. RESTORATIVE, PASTE/LIQUID | Dec 28, 1988 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K884352 | SMILE-DENT ANTE./POST. RESTORATIVE, LIGHT-CURED | Dec 22, 1988 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K884038 | FIBERLITE, FIBERLITE HS AND FIBERSEAL | Dec 07, 1988 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K882566 | VISIO-PERL | Oct 19, 1988 | Substantially Equivalent | ESPE GMBH (US) |
| K883392 | LUMINBOND, BONDING AND CEMENTATION SYSTEM | Oct 18, 1988 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K882915 | FORTIFY | Aug 12, 1988 | Substantially Equivalent | BISCO, INC. |
| K882576 | ACID ETCH GEL | Jul 15, 1988 | Substantially Equivalent | PULPDENT CORP. OF AMERICA |
| K882400 | AMORPHUS SILK BY DENTRAX | Jul 15, 1988 | Substantially Equivalent | DALE T. DUPUIS |
| K881903 | PROSTHODENT VL | Jul 01, 1988 | Substantially Equivalent | LEE PHARMACEUTICALS |
| K882006 | CLEARFIL PHOTO CORE | Jun 13, 1988 | Substantially Equivalent | KURARAY CO. |
| K880765 | G-CERA PORCELAIN BOND | Apr 18, 1988 | Substantially Equivalent | G-C INTL. CORP. |
| K875313 | PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST | Mar 10, 1988 | Substantially Equivalent | BISCO, INC. |
| K872588 | CLEARFIL PHOTO POSTERIOR | Mar 02, 1988 | Substantially Equivalent | KURARAY CO. |
| K875256 | BISCOLOR | Feb 26, 1988 | Substantially Equivalent | BISCO, INC. |
| K874189 | DUAL-CURE RADIOPAQUE | Feb 11, 1988 | Substantially Equivalent | PENTRON CORP. |
| K873123 | LEE COMPOSITE INLAY SYSTEM | Jan 20, 1988 | Substantially Equivalent | LEE PHARMACEUTICALS |
| K874275 | OPTEC SUPPLEMENTARY KIT | Jan 19, 1988 | Substantially Equivalent | PENTRON CORP. |
| K874162 | OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT | Jan 12, 1988 | Substantially Equivalent | PENTRON CORP. |
| K873683 | CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL) | Nov 16, 1987 | Substantially Equivalent | PENTRON CORP. |
| K873886 | CLEARFIL PORCELAIN REPAIR SYSTEM | Nov 12, 1987 | Substantially Equivalent | KURARAY CO. |
| K873878 | #24L SYSTEM | Oct 27, 1987 | Substantially Equivalent | PENTRON CORP. |
| K872444 | SILUX PLUS LIGHT CURED RESTORATIVE MATERIAL | Sep 11, 1987 | Substantially Equivalent | 3M COMPANY |
| K872510 | DEN-MAT TENURE | Aug 24, 1987 | Substantially Equivalent | DEN-MAT CORP. |
| K872960 | CLEARFIL POSTERIOR NEW BOND | Aug 11, 1987 | Substantially Equivalent | KURARAY CO. |
| K872907 | DENTIN ADHESIVE | Aug 03, 1987 | Substantially Equivalent | DENTSPLY INTL. |
| K872890 | SYNERGY | Aug 03, 1987 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K872569 | TEMREX ETCHING GEL | Jul 21, 1987 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K871899 | IMPERVA-A | Jul 21, 1987 | Substantially Equivalent | SHOFU DENTAL CORP. |
| K871898 | IMPERVA-P | Jul 21, 1987 | Substantially Equivalent | SHOFU DENTAL CORP. |
| K871637 | CLEARFIL CORE NEW BOND | Jul 17, 1987 | Substantially Equivalent | KURARAY CO. |
| K871634 | CLEARFIL FII NEW BOND | Jul 17, 1987 | Substantially Equivalent | KURARAY CO. |
| K871635 | CLEARFIL POSTERIOR 3 | Jul 16, 1987 | Substantially Equivalent | KURARAY CO. |
| K872243 | PEKALUX(TM) | Jul 07, 1987 | Substantially Equivalent | COLUMBUS DENTAL MFG. CO. |
| K872279 | SCOTCHBOND 2 ADHESIVE W/SCOTCHPREP DENTIN PRIMER | Jul 02, 1987 | Substantially Equivalent | 3M COMPANY |
| K872272 | PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS | Jul 02, 1987 | Substantially Equivalent | COLUMBUS DENTAL MFG. CO. |
| K871164 | GLUMA(TM) BONDING SYSTEM | Jul 02, 1987 | Substantially Equivalent | COLUMBUS DENTAL MFG. CO. |
| K871295 | ADAPTALITE* PORCELAIN VENEER CEMENTATION SYSTEM | May 29, 1987 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K871270 | PERFORM DENTURE BASE RESIN | May 29, 1987 | Substantially Equivalent | IPCO CORP. |
| K871165 | LUMIFOR(TM) COMPOSITE | Apr 03, 1987 | Substantially Equivalent | COLUMBUS DENTAL MFG. CO. |
| K870628 | MICROBOND COMPOSITE KIT FOR CERAMIC BONDING SYSTEM | Mar 06, 1987 | Substantially Equivalent | CHEM-E-DENT |
| K870266 | COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM | Feb 27, 1987 | Substantially Equivalent | COLTENE, INC. |
| K865028 | ESPE CHELON-SILVER | Feb 19, 1987 | Substantially Equivalent | ESPE GMBH (US) |
| K864710 | ISOSIT N | Feb 10, 1987 | Substantially Equivalent | IVOCLAR USA, INC. |
| K864346 | REMBRANDT PORCELAIN TINTING KIT | Jan 07, 1987 | Substantially Equivalent | DEN-MAT CORP. |
| K863876 | OMNI-FIL | Nov 26, 1986 | Substantially Equivalent | INPROMAS |
| K863882 | OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE | Nov 18, 1986 | Substantially Equivalent | COE LABORATORIES, INC. |
| K863401 | RECOVER | Nov 13, 1986 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K863552 | IMPROVED COMSPAN | Oct 17, 1986 | Substantially Equivalent | DENTSPLY INTL. |
| K862546 | MICROFILL PONTIC | Oct 14, 1986 | Substantially Equivalent | KULZER, INC. |
| K863174 | CAULK'S POLISHING PASTE | Oct 07, 1986 | Substantially Equivalent | DENTSPLY INTL. |
| K863157 | RESTODENT POSTERIOR | Sep 25, 1986 | Substantially Equivalent | LEE PHARMACEUTICALS |
| K863315 | MULTIFIL(R) VS | Sep 22, 1986 | Substantially Equivalent | KULZER, INC. |
| K863314 | ESTILUX(R) POSTERIOR C | Sep 22, 1986 | Substantially Equivalent | KULZER, INC. |
| K863031 | TWIN-CORE | Sep 22, 1986 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K863092 | DENTAL COMPOSITE RESTORATIVE | Sep 19, 1986 | Substantially Equivalent | DENTSPLY INTL. |
| K862942 | PHOTO CLEARFIL BRIGHT | Sep 05, 1986 | Substantially Equivalent | KURARAY CO. |
| K862292 | ESPE VISIO-MOLAR | Aug 18, 1986 | Substantially Equivalent | ESPE GMBH (US) |
| K862232 | PANAVIA TC, AND PANAVIA OPAQUE | Jul 29, 1986 | Substantially Equivalent | KURARAY CO. |
| K862449 | DEN-MAT DENTIN LINK | Jul 22, 1986 | Substantially Equivalent | DEN-MAT CORP. |
| K862648 | V-BOND, PAINT-ON COMPOSITE RESTOR/VENEER CEMENT | Jul 18, 1986 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K861833 | RESTOR (COMET)*DENTAL RESTORATIVE | Jul 09, 1986 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K861899 | SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE | Jun 25, 1986 | Substantially Equivalent | 3M COMPANY |
| K860487 | URENAMEL, POSTERIOR RESTORATIVE MATERIAL | May 30, 1986 | Substantially Equivalent | CADCO DENTAL PRODUCTS, INC. |
| K861740 | P-50 LIGHT CURED RESIN BONDED CERAMIC | May 21, 1986 | Substantially Equivalent | 3M COMPANY |
| K861546 | REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT | May 21, 1986 | Substantially Equivalent | MACROCHEM CORP. |
| K861148 | BISCO'S PORCELAIN VENEER SYSTEM | Apr 30, 1986 | Substantially Equivalent | BISCO, INC. |
| K860708 | PHOTO CLEARFIL OPAQUER | Apr 17, 1986 | Substantially Equivalent | KURARAY CO. |
| K860626 | NUCOR COMPOSITE RESTORATIVE MATERIAL PASTE/LIQUID | Apr 08, 1986 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K860627 | SCI-PHARM UNIFIL ANTERIOR/POSTERIOR LIQUID/PASTE | Mar 26, 1986 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K854755 | RENAMEL ESTHETIC RESTORATIVE SYSTEM | Mar 13, 1986 | Substantially Equivalent | COSMEDENT, INC. |
| K854803 | CHAMELEON BONDING KIT | Mar 04, 1986 | Substantially Equivalent | PENTRON CORP. |
| K853055 | LIGHT CURE FILLING MATERIAL | Nov 19, 1985 | Substantially Equivalent | FOREMOST DENTAL MFG., INC. |
| K853431 | DENTAL CEMENT | Oct 31, 1985 | Substantially Equivalent | DENTSPLY INTL. |
| K852868 | WUNDERSHADE | Sep 27, 1985 | Substantially Equivalent | HARRY J. BOSWORTH CO. |
| K853002 | BISFIL-II(CHEMICAL CURABLE POSTERIOR/ANTERIOR) | Aug 16, 1985 | Substantially Equivalent | BISCO, INC. |
| K853001 | BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE) | Aug 16, 1985 | Substantially Equivalent | BISCO, INC. |
| K852745 | PORCELAIN VENEER SYSTEM BONDING KIT | Aug 16, 1985 | Substantially Equivalent | THE S. S. WHITE CO. |
| K852744 | CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLOR | Aug 16, 1985 | Substantially Equivalent | THE S. S. WHITE CO. |
| K851929 | RESTORE* | Jul 31, 1985 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K852659 | BIOGLOSS | Jul 30, 1985 | Substantially Equivalent | DENTSPLY INTL. |
| K852658 | ETEN-GEL | Jul 24, 1985 | Substantially Equivalent | DENTSPLY INTL. |
| K852344 | DISTALITE POSTERIA DENTAL RESTORATIVE | Jul 01, 1985 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K852151 | PHOTO CURING LIGHT | Jul 01, 1985 | Substantially Equivalent | DENTSPLY INTL. |
| K851459 | VISILUX 2 VISIBLE LIGHT CURING UNIT | May 21, 1985 | Substantially Equivalent | 3M COMPANY |
| K850965 | KULZER DENTIN ADHESIVE | Apr 22, 1985 | Substantially Equivalent | KULZER, INC. |
| K850911 | TRIAD C & B MATERIAL | Apr 16, 1985 | Substantially Equivalent | DENTSPLY INTL. |
| K850824 | PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST | Apr 08, 1985 | Substantially Equivalent | KURARAY CO. |
| K844662 | KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI | Mar 25, 1985 | Substantially Equivalent | KERR CORPORATION (DANBURY) |
| K845033 | FOREMOST DENTIN ADHESIVE | Mar 18, 1985 | Substantially Equivalent | FOREMOST DENTAL MFG., INC. |
| K844326 | OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE | Dec 03, 1984 | Substantially Equivalent | COE LABORATORIES, INC. |
| K843363 | RESTODENT VL | Oct 25, 1984 | Substantially Equivalent | LEE PHARMACEUTICALS |
| K843026 | KERR GELLED PHOSPHORIC ACID ETCHANT | Sep 27, 1984 | Substantially Equivalent | KERR CORPORATION (DANBURY) |
| K843072 | EVER-BOND V GLASS LONOMER RESTORATIVE | Sep 07, 1984 | Substantially Equivalent | KERR CORPORATION (DANBURY) |
| K842087 | BISFIL-I LIGHT CURABLE POSTERIOR COMPO | Jul 12, 1984 | Substantially Equivalent | BISCO, INC. |
| K841550 | SCOTCHBOND LIGHT CURED DENTAL ADHES | Jun 22, 1984 | Substantially Equivalent | 3M COMPANY |
| K841667 | WUNDERFIL | May 22, 1984 | Substantially Equivalent | HARRY J. BOSWORTH CO. |
| K841269 | C-19 | May 22, 1984 | Substantially Equivalent | PENTRON CORP. |
| K841268 | C-17 | May 22, 1984 | Substantially Equivalent | PENTRON CORP. |
| K841518 | JOHNSON & JOHNSON POSTERIOR DENTAL (ADAPTIC II) | May 21, 1984 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K841267 | C-18 | Apr 30, 1984 | Substantially Equivalent | PENTRON CORP. |
| K833797 | LIGHT CURED RESIN BONDED CERAMIC | Apr 25, 1984 | Substantially Equivalent | 3M COMPANY |
| K840727 | PENTRA-FIL II | Apr 13, 1984 | Substantially Equivalent | PENTRON CORP. |
| K840176 | ESTIC MICROFILL | Apr 13, 1984 | Substantially Equivalent | KULZER, INC. |
| K841111 | REMBRANDT SHADE MODIFICATION KIT | Mar 30, 1984 | Substantially Equivalent | DEN-MAT CORP. |
| K840084 | COLTENE BRILLIANT LUX | Mar 30, 1984 | Substantially Equivalent | BAUER, CHENG & ASSOCIATES, INC. |
| K833725 | PRE-LOADED C-R TUBES FOR SYRINGE | Mar 30, 1984 | Substantially Equivalent | CENTRIX, INC. |
| K840085 | COLTENE BRILLIANT | Mar 16, 1984 | Substantially Equivalent | BAUER, CHENG & ASSOCIATES, INC. |
| K833810 | CURAY-MATCH PAINT-ON COMPOSITE RESTOR | Feb 21, 1984 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K834247 | MATERIAL TOOTHSADE RESIN | Feb 10, 1984 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K834046 | LUXENE VINYL-JECT 3600-80 | Feb 03, 1984 | Substantially Equivalent | HOWMEDICA CORP. |
| K833757 | VISIO-GEM | Feb 03, 1984 | Substantially Equivalent | ESPE GMBH (US) |
| K831351 | PERMALUX VISIBLE CURE COMPOSITE RESTOR | Nov 14, 1983 | Substantially Equivalent | LARES MANUFACTURING CO., INC. |
| K832781 | CURAY-SUPPORT, CORE BUILD-UP MATERIAL | Oct 19, 1983 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K831215 | DENTACOLOR LIGHT CURING CROWN & BRIDGE | Sep 12, 1983 | Substantially Equivalent | KULZER, INC. |
| K832062 | ADAPTIC*FAST SET DENTAL RESTORATIVE | Aug 31, 1983 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K832061 | LIGHT CURING BONDING AGENT | Aug 31, 1983 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K831484 | COMPOSI-GLAZE | Jul 28, 1983 | Substantially Equivalent | DENPAC CORP. |
| K831559 | CERTAIN *DENTAL RESTORATIVE | Jun 30, 1983 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K830513 | FIRST TM | May 09, 1983 | Substantially Equivalent | PHASEALLOY |
| K830442 | PRISMA-FINE | Mar 17, 1983 | Substantially Equivalent | DENTSPLY INTL. |
| K830380 | MICRODAPT DENTAL RESTORATIVE | Mar 17, 1983 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K823510 | CURAY ANTERIOR/POSTERIOR RESTORATIVE | Dec 28, 1982 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K823185 | GAMMA LIGHT CURING DENTAL RESTORATIVE | Nov 22, 1982 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K822453 | VISIO-OPAQUER | Sep 14, 1982 | Substantially Equivalent | ESPE GMBH (US) |
| K822450 | AURAFILL* DENTAL RESTORATIVE | Sep 14, 1982 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K821895 | AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR | Jul 16, 1982 | Substantially Equivalent | AMERICAN MIDWEST |
| K820028 | ZEON COMPOSITE RESIN LIGHT CURE SYS | Mar 11, 1982 | Substantially Equivalent | NATIONAL PATENT DEVELOPMENT CORP. |
| K820182 | SYBRON/KERR COMMAND | Mar 02, 1982 | Substantially Equivalent | SYBRON CORP. |
| K813568 | ESTILUX POSTERIOR XR | Jan 29, 1982 | Substantially Equivalent | KULZER, INC. |
| K820006 | ZEON COMPOSITE RESIN SYSTEM | Jan 22, 1982 | Substantially Equivalent | NATIONAL PATENT DEVELOPMENT CORP. |
| K813357 | CAULK OPAQUER | Jan 07, 1982 | Substantially Equivalent | DENTSPLY INTL. |
| K813090 | COMPOSITE DENTAL RESTORATIVE MATERIAL | Nov 24, 1981 | Substantially Equivalent | SCI-PHARM, INC. |
| K812889 | ESTILUX POSTERIOR | Nov 17, 1981 | Substantially Equivalent | KULZER, INC. |
| K812546 | BEAUDENT | Sep 25, 1981 | Substantially Equivalent | SCI-PHARM, INC. |
| K812545 | BEAUFILL | Sep 25, 1981 | Substantially Equivalent | SCI-PHARM, INC. |
| K812449 | ADAPTIC* C.F.S. | Sep 25, 1981 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K812551 | BEAUCOR | Sep 23, 1981 | Substantially Equivalent | SCI-PHARM, INC. |
| K812169 | VISIO-FIL | Sep 08, 1981 | Substantially Equivalent | ESPE GMBH (US) |
| K812119 | NIMETIC-DISPERS | Aug 31, 1981 | Substantially Equivalent | ESPE-PREMIER SALES CO. |
| K811427 | SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM | Aug 20, 1981 | Substantially Equivalent | HARRY J. BOSWORTH CO. |
| K811979 | ATT-1 DENTAL COMPOSITE RESTORATIVE SYS | Aug 18, 1981 | Substantially Equivalent | AMERICAN MIDWEST |
| K811669 | DURAFILL MICROFILL RESTORATIVE MATERIAL | Jul 01, 1981 | Substantially Equivalent | KULZER, INC. |
| K811443 | ENHANCE DENTAL RESTORATIVE | Jun 16, 1981 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K811363 | COLTENE DRS DENTAL RESTORATIVE SYSTEM | Jun 16, 1981 | Substantially Equivalent | COLTENE, INC. |
| K810969 | ISOSIT C & B MATERIAL | May 05, 1981 | Substantially Equivalent | BAUER, CHENG & ASSOCIATES, INC. |
| K810595 | SILUX RESTORATIVE MATERIAL & ENAMEL BOND | Mar 24, 1981 | Substantially Equivalent | 3M COMPANY |
| K810479 | SUPPORT | Mar 17, 1981 | Substantially Equivalent | SCI-PHARM, INC. |
| K803227 | VISIO-DISPERS | Jan 14, 1981 | Substantially Equivalent | ESPE-PREMIER SALES CO. |
| K802975 | ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE | Jan 14, 1981 | Substantially Equivalent | DENTSPLY INTL. |
| K802535 | HYDROXYLATE DENTAL COMPOSITE RESTROATIVE | Dec 18, 1980 | Substantially Equivalent | WALLACE A. ERICKSON & CO. |
| K802683 | HELIOSIT | Nov 24, 1980 | Substantially Equivalent | VIVADENT (USA), INC. |
| K802680 | ISOPAST-DS | Nov 12, 1980 | Substantially Equivalent | VIVADENT (USA), INC. |
| K802125 | ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE | Sep 16, 1980 | Substantially Equivalent | DENTSPLY INTL. |
| K802049 | NIMETIC-DISPERS | Sep 16, 1980 | Substantially Equivalent | ESPE DENTAL PRODUCTS |
| K801798 | COMPOSITE RESTORATIVE, PASTE/PASTE TYPE | Aug 07, 1980 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K801797 | SCI-PHARM PAINT-ON RESTORATIVE | Aug 07, 1980 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K801732 | PRISMA-FIL | Aug 07, 1980 | Substantially Equivalent | DENTSPLY INTL. |
| K801529 | KERR CORE COMPOSITE | Aug 04, 1980 | Substantially Equivalent | SYBRON CORP. |
| K801237 | REIGNING CROWN-BRIDGE/POLYCARB. RESIN | Jun 09, 1980 | Substantially Equivalent | OKI SHIKS USA LTD. |
| K801092 | PRISMA-FILL | May 20, 1980 | Substantially Equivalent | DENTSPLY INTL. |
| K800439 | ADR COMPOSITE RESTORATIVE | Mar 12, 1980 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K792140 | COMPOSITE RESTORATIVE, PASTE/TYPE | Nov 30, 1979 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K792303 | MW 8000-I | Nov 27, 1979 | Substantially Equivalent | MIDWEST |
| K791602 | SCI-PHARM POLIFIL ANTERIOR RESTORATIVE | Nov 27, 1979 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K790823 | VISIO-DISPERS | Oct 22, 1979 | Substantially Equivalent | ESPE GMBH (US) |
| K791318 | MIRADAPT* DENTAL RESTORATIVE | Sep 12, 1979 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K790963 | PAINT-ON RESTORATIVE, LIGHT CURED | Jul 06, 1979 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K790822 | ANTERIOR/POSTERIOR RESTORATIVE LIQUID | Jul 06, 1979 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K790789 | COMPOSITE RESTORATIVE, PASTE/PASTE TYPE | Jul 06, 1979 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K790594 | DENTAL COMPOSITE RESTORATIVE MATERIAL | Jun 15, 1979 | Substantially Equivalent | WALLACE A. ERICKSON & CO. |
| K790585 | FINESSE | May 16, 1979 | Substantially Equivalent | L.D. CAULK CO. |
| K790439 | CONTACT RESIN | Apr 10, 1979 | Substantially Equivalent | VIVADENT (USA), INC. |
| K782165 | PHASEAFILL | Mar 21, 1979 | Substantially Equivalent | PHASEALLOY |
| K781787 | ISOPLAST | Dec 20, 1978 | Substantially Equivalent | VIVADENT (USA), INC. |
| K781687 | AUROFIL | Dec 04, 1978 | Substantially Equivalent | WALLACE A. ERICKSON & CO. |
| K781580 | PERFIT DENTAL RESTORATIVE COMPOSITE | Oct 11, 1978 | Substantially Equivalent | LOCITE CORP. |
| K781293 | RESTORATIVE SYSTEM PROFILE | Aug 18, 1978 | Substantially Equivalent | THE S. S. WHITE CO. |
| K780965 | NEW RESTODENT | Jun 22, 1978 | Substantially Equivalent | LEE PHARMACEUTICALS |
| K780796 | ZYTRON | Jun 22, 1978 | Substantially Equivalent | PREMIER DENTAL PRODUCTS CO. |
| K780833 | ESTIC MICROFILL | Jun 14, 1978 | Substantially Equivalent | DEGUSSA DENTAL, INC. |
| K780832 | ESTILUX MICROFILL | Jun 14, 1978 | Substantially Equivalent | DEGUSSA DENTAL, INC. |
| K772279 | FOTOFILL DENTAL RESTORATIVE | Jan 03, 1978 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K771882 | REPLICA DENTAL COMPOSITE-RADIOPAQUE | Oct 20, 1977 | Substantially Equivalent | HOYT LABORATORIES |
| K771880 | REPLICA DENTAL COMPOSIT | Oct 20, 1977 | Substantially Equivalent | HOYT LABORATORIES |
| K771654 | NIMETICAP | Sep 06, 1977 | Substantially Equivalent | ESPE GMBH (US) |
| K771404 | NUVA-FIL COMPOSITE RESTORATIVE (MODI.) | Aug 03, 1977 | Substantially Equivalent | L.D. CAULK CO. |
| K771247 | CORE MATERIAL | Jul 15, 1977 | Substantially Equivalent | STAR DENTAL MFG. CO. |
| K771119 | PASTES, RESTORATIVE & TINTED, DEBTAL | Jul 15, 1977 | Substantially Equivalent | ESPE DENTAL PRODUCTS |
| K770922 | DENTAL RESTORATIVE IN CAPSULES | Jun 01, 1977 | Substantially Equivalent | ESPE GMBH (US) |
| K770109 | ENAMELITE ENAMEL COATING | Jan 24, 1977 | Substantially Equivalent | LEE PHARMACEUTICALS |
| K770055 | COMPOSITE RESTORATIVE MATERIAL, PRESTIGE | Jan 14, 1977 | Substantially Equivalent | LEE PHARMACEUTICALS |
| K760979 | COMPOSITE MATERIAL | Nov 15, 1976 | Substantially Equivalent | ADP INTL., INC. |
| K760417 | LEE-FILL ULTRAVIOLET-CURED REST. MAT. | Aug 23, 1976 | Substantially Equivalent | LEE PHARMACEUTICALS |
| K760377 | FILLING, RESIN DENTAL (VYTOL) | Aug 23, 1976 | Substantially Equivalent | L.D. CAULK CO. |
| K760369 | POWDERLITE | Aug 11, 1976 | Substantially Equivalent | THE S. S. WHITE CO. |
FEI Numbers
This FDA classification entry is associated with 205 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 205 registration numbers. Click on an entry to view related FDA registrations.