Product Code: EBG
FDA class 2
21 CFR 872.3770
Crown And Bridge, Temporary, Resin
Dental
The Temporary Crown and Bridge Resin is a dental material used to fabricate provisional restorations that protect prepared teeth and maintain esthetics and function while a permanent prosthesis is being fabricated in the laboratory. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is EBG and the applicable regulation is 21 CFR 872.3770, under the Dental medical specialty. This device is eligible for third-party 510(k) review.
510(k)s
187
FEI Numbers
183
Registration Numbers
183
Unique Applicants
138
Years Active
48
Basic Information
- Product Code
- EBG
- Device Class
- FDA class 2
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 187 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251271 | TempFIT Temporary Crown and Bridge Resin | Jun 23, 2025 | Substantially Equivalent | Rizhao HuGe Biomaterials Company, Ltd. |
| K243370 | DentaTOOTH | May 05, 2025 | Substantially Equivalent | Asiga Pty Ltd |
| K243621 | Evoblock, Perléon | Apr 22, 2025 | Substantially Equivalent | Evoden Indústria Comércio Importação e Exportação |
| K243951 | TEMP MASTER, PMMA-based dental resin | Feb 21, 2025 | Substantially Equivalent | Taiwan Dental Materials CO., LTD. |
| K242559 | Digital Temp | Nov 26, 2024 | Substantially Equivalent | SprintRay Inc. |
| K231859 | PrimmaArt | Nov 26, 2024 | Substantially Equivalent | DentsCare LTDA |
| K240538 | Premium Teeth Resin | Jul 19, 2024 | Substantially Equivalent | Formlabs Ohio, Inc. |
| K241226 | Fixtemp® C&B 4:1 | May 31, 2024 | Substantially Equivalent | Dreve Denatmid GmbH |
| K233868 | dima Print Teeth & Temp | May 23, 2024 | Substantially Equivalent | Kulzer, LLC |
| K223706 | PMMA BLOCK | May 12, 2023 | Substantially Equivalent | Huliang(shanghai) Bio-Tech Co., Ltd. |
| K223477 | PMMA Blocks for Dental Use | Feb 16, 2023 | Substantially Equivalent | Aidite (Qinhuangdao) Technology Co., Ltd. |
| K202965 | CURA-Temp | Dec 21, 2022 | Substantially Equivalent | Mgnewton LTD. |
| K214071 | Hexa-Temp | Mar 10, 2022 | Substantially Equivalent | SPIDENT CO., LTD. |
| K213643 | UltraPrint-Dental Temp C&B UV | Jan 14, 2022 | Substantially Equivalent | Guangzhou Heygears Imc. Inc |
| K210817 | C&B 5.0 Hybrid | Dec 08, 2021 | Substantially Equivalent | Arum Dentistry Co., Ltd |
| K211101 | E-Temp | Jun 14, 2021 | Substantially Equivalent | EnvisionTEC GmbH |
| K201563 | PuRE PMMA Disc | Apr 09, 2021 | Substantially Equivalent | Quest Dental USA Corp. |
| K190217 | Aidite PMMA | Dec 17, 2020 | Substantially Equivalent | Aidite (Qinhuangdao) Technology Co., Ltd. |
| K201827 | GR-17 Resin System | Nov 05, 2020 | Substantially Equivalent | Pro3dure Medical GmbH |
| K201683 | PMMA Block | Nov 03, 2020 | Substantially Equivalent | Huge Dental Material Co., Ltd. |
| K200273 | FREEPRINT temp | Oct 27, 2020 | Substantially Equivalent | DETAX GmbH & Co.KG |
| K201090 | Structur CAD | Sep 09, 2020 | Substantially Equivalent | VOCO GmbH |
| K192830 | Bright Temporary C&B | Sep 02, 2020 | Substantially Equivalent | DMP Dental Industry S.A. |
| K200039 | P pro Crown & Bridge | Jul 31, 2020 | Substantially Equivalent | DeltaMed GmbH |
| K193113 | GC Temp Print | Jul 09, 2020 | Substantially Equivalent | GC America Inc. |
| K200676 | ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA | Jul 08, 2020 | Substantially Equivalent | Zirkonzahn srl |
| K193553 | VarseoSmile Temp | May 18, 2020 | Substantially Equivalent | BEGO Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG |
| K191590 | AA temp temporary restoration 3D printing photoreactive resin | May 05, 2020 | Substantially Equivalent | Enlighten Materials Co., Ltd |
| K192158 | DiaTemp | Feb 13, 2020 | Substantially Equivalent | Diadent Group International |
| K192022 | DiaTemp Flow | Feb 13, 2020 | Substantially Equivalent | Diadent Group International |
| K192806 | DENTCA Crown and Bridge | Feb 05, 2020 | Substantially Equivalent | Dentca, Inc. |
| K192153 | Portux CAD/CAM Disc | Nov 07, 2019 | Substantially Equivalent | New Stetic S.A. |
| K191843 | Ceramill A-Temp | Oct 04, 2019 | Substantially Equivalent | Amann Girrbach AG |
| K191619 | TurboTemp EZ | Sep 11, 2019 | Substantially Equivalent | Zest Anchors, LLC |
| K190930 | SmarTemp X1 | Sep 05, 2019 | Substantially Equivalent | Parkell, Inc. |
| K190724 | MD-Temp Plus | Jul 03, 2019 | Substantially Equivalent | Meta Biomed Co., Ltd |
| K183337 | LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 | May 29, 2019 | Substantially Equivalent | DMG Chemisch-Pharmazeutische Fabrik GmbH |
| K182065 | EVOLUX CAD/CAM PMMA BLOCKS | Dec 13, 2018 | Substantially Equivalent | Blue Dent Dental |
| K180578 | Harvest Dental Polymer Blocks | Dec 12, 2018 | Substantially Equivalent | Harvest Dental Products, LLC |
| K180657 | Resin for Temporary Crown & Bridge | Dec 07, 2018 | Substantially Equivalent | Dentis Co., Ltd. |
| K180562 | TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT | Jun 28, 2018 | Substantially Equivalent | Zirkonzahn Gmbh |
| K171729 | Fixtemp C&B | Dec 13, 2017 | Substantially Equivalent | Dreve Dentamid GmbH |
| K172281 | PuRE PMMA Disc | Oct 19, 2017 | Substantially Equivalent | Quest Dental USA Corp. |
| K153490 | DD medical polymers | May 13, 2016 | Substantially Equivalent | DENTAL DIREKT GMBH |
| K152443 | Vericore Gradient Temporary Disc | May 11, 2016 | Substantially Equivalent | WHIP MIX CORPORATION |
| K153753 | TelioCAD Multi | Apr 12, 2016 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K152215 | DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR | Jan 19, 2016 | Substantially Equivalent | DENTALPLUS GMBH |
| K151764 | YAMAHACHI PMMA DISKS | Nov 23, 2015 | Substantially Equivalent | YAMAHACHI DENTAL PRODUCTS USA, INC. |
| K151144 | SuPro 100 | Sep 14, 2015 | Substantially Equivalent | 3M DEUTSCHLAND GMBH |
| K150432 | IDODENTINE DISC, IDODENTINE BLOCK | Aug 14, 2015 | Substantially Equivalent | UNION DENTAL S.A. |
| K142371 | Luminesse PMMA | Apr 24, 2015 | Substantially Equivalent | TALLADIUM, INC. |
| K133268 | TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS | Feb 12, 2015 | Substantially Equivalent | SCHUTZ-DENTAL GMBH |
| K141421 | PMMA BLOCK | Feb 09, 2015 | Substantially Equivalent | RIZHAO HUGE DENTAL INDUSTRY CO., LTD |
| K141562 | MSN-006 | Sep 05, 2014 | Substantially Equivalent | GC AMERICA, INC. |
| K140894 | ARGEN PMMA | Jul 31, 2014 | Substantially Equivalent | THE ARGEN CORPORATION |
| K132937 | HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) | May 21, 2014 | Substantially Equivalent | HARVEST DENTAL PRODUCTS, LLC |
| K131664 | COPRA TEMP PMMA-DISK | Dec 18, 2013 | Substantially Equivalent | WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG |
| K123638 | PEKKTON IVORY | Feb 21, 2013 | Substantially Equivalent | CENDRES & METAUX SA |
| K122039 | KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B | Dec 27, 2012 | Substantially Equivalent | KETTENBACH GMBH & CO KG |
| K122025 | BRIGHTGLASS BRIGHTGLASS M | Oct 09, 2012 | Substantially Equivalent | KTK MEDICAL SUPPLIES GMBH |
| K112967 | PMMA CAD/CAM DISC | Aug 28, 2012 | Substantially Equivalent | POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY |
| K120784 | TUFF-TEMP 2.0 | Jun 08, 2012 | Substantially Equivalent | PULPDENT CORPORATION |
| K120779 | STRUCTUR 3 | Jun 01, 2012 | Substantially Equivalent | VOCO GMBH |
| K112186 | FIBER DISK AND BLOCK | Nov 08, 2011 | Substantially Equivalent | BIOLOREN SRL |
| K111666 | EVADYNE TEMPORARY CROWN AND BRIDGE RESIN | Sep 07, 2011 | Substantially Equivalent | NEO DENTAL CHEMICAL PRODUCTS CO., LTD. |
| K102917 | FIXTEMP C&B | Jun 17, 2011 | Substantially Equivalent | EXACTA DENTAL DIRECT, INC |
| K110747 | TEMPFLEX | Jun 14, 2011 | Substantially Equivalent | KERR CORPORATION |
| K103514 | PRO-V COAT | May 25, 2011 | Substantially Equivalent | BISCO, INC. |
| K110484 | SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL | May 17, 2011 | Substantially Equivalent | NOVOCOL, INC. |
| K102776 | EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM | Feb 18, 2011 | Substantially Equivalent | DELTAMED GMBH |
| K103379 | TELIO CS INLAY & TELIO CS ONLAY | Feb 14, 2011 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K103474 | ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) | Feb 07, 2011 | Substantially Equivalent | MICERIUM S.P.A. |
| K102753 | TURBO TEMP 3 | Feb 04, 2011 | Substantially Equivalent | DANVILLE MATERIALS, INC. |
| K102341 | VIPI BLOCK | Dec 16, 2010 | Substantially Equivalent | VIPI INDUSTRIA,COMERCIO,EXPORTACAO E IMPORTACAO DE |
| K101710 | LUXATEMP ULTRA /STAR | Sep 28, 2010 | Substantially Equivalent | DMG USA, INC. |
| K101814 | DIRECT CROWN NATURAL 1 | Sep 27, 2010 | Substantially Equivalent | CANDULOR USA, INC. |
| K093708 | TELIO CAD | Mar 10, 2010 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K093380 | MIZZY EXPRESS | Mar 05, 2010 | Substantially Equivalent | MYCONE DENTAL SUPPLY CO., INC. |
| K091894 | TEMPORARY C&B COMPOSITE | Jul 23, 2009 | Substantially Equivalent | VOCO GMBH |
| K083195 | MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN | Jun 05, 2009 | Substantially Equivalent | LANG DENTAL MFG. CO., INC. |
| K082700 | TEMPORARY COLD.V AND SELF-CURE DENTINE | Dec 09, 2008 | Substantially Equivalent | MAJOR PRODOTTI DENTARI S.P.A. |
| K081810 | PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL | Sep 17, 2008 | Substantially Equivalent | PULPDENT CORPORATION |
| K081705 | LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN | Sep 17, 2008 | Substantially Equivalent | LANG DENTAL MFG. CO., INC. |
| K080556 | ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES | May 02, 2008 | Substantially Equivalent | MERZ DENTAL GMBH |
| K080311 | MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM | Apr 18, 2008 | Substantially Equivalent | DENTSPLY INTERNTIONAL |
| K073106 | UNIFAST III | Apr 11, 2008 | Substantially Equivalent | GC AMERICA, INC. |
| K080182 | ZENO PMMA DISC | Apr 08, 2008 | Substantially Equivalent | WIELAND DENTAL + TECHNIK GMBH & CO. KG |
| K073263 | PRO-V | Feb 14, 2008 | Substantially Equivalent | BISCO, INC. |
| K073296 | TEMPXN28 | Jan 09, 2008 | Substantially Equivalent | 3M ESPE AG DENTAL PRODUCTS |
| K071548 | WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED | Aug 21, 2007 | Substantially Equivalent | MERZ DENTAL GMBH |
| K070991 | VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310 | Jun 01, 2007 | Substantially Equivalent | VITA |
| K063624 | KAVO EVEREST C-TEMP | Feb 08, 2007 | Substantially Equivalent | KAVO AMERICA |
| K061809 | ARTEGRAL IMCROWN | Sep 13, 2006 | Substantially Equivalent | MERZ DENTAL GMBH |
| K061530 | MD-TEMP | Jul 21, 2006 | Substantially Equivalent | META BIOMED CO., LTD. |
| K061264 | TEMPFX ESTHETIC PROVISIONAL SYSTEM | May 23, 2006 | Substantially Equivalent | DENTSPLY INTERNATIONAL, INC. |
| K060881 | TEMPORARY CROWN & BRIDGE RESIN | May 16, 2006 | Substantially Equivalent | COSMEDENT, INC. |
| K052800 | PROVISIONAL INLAY/ONLAY KIT | Mar 07, 2006 | Substantially Equivalent | DMG USA, INC. |
| K060293 | TEMPORARY CROWN AND BRIDGE MATERIAL | Feb 17, 2006 | Substantially Equivalent | DENTSPLY INTERNATIONAL, INC. |
| K052781 | BREFORMANCE | Dec 09, 2005 | Substantially Equivalent | BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT |
| K042820 | SYSTEMP.C&B PLUS | Dec 14, 2004 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K041886 | PROVISO | Aug 04, 2004 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K040951 | SR ADORO | May 19, 2004 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K041098 | COOL TEMP NATURAL | May 13, 2004 | Substantially Equivalent | COLTENE AG |
| K040769 | STRUCTUR 2 SC | Apr 07, 2004 | Substantially Equivalent | VOCO GMBH |
| K033227 | LUXAFORM PLUS | Jan 16, 2004 | Substantially Equivalent | DMG USA, INC. |
| K033432 | LEXATITE QUICK ACRYLIC | Jan 15, 2004 | Substantially Equivalent | IMTEC CORP. |
| K033022 | PROTEMP 3 GARANT | Nov 21, 2003 | Substantially Equivalent | 3M ESPE AG DENTAL PRODUCTS |
| K031476 | FILL-IN | Jul 02, 2003 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K024282 | ACRYLIC | Mar 21, 2003 | Substantially Equivalent | INOVATIV, LLC |
| K023079 | NEW OUTLINE | Oct 30, 2002 | Substantially Equivalent | ANAXDENT GMBH |
| K022030 | POLY-CARB | Aug 28, 2002 | Substantially Equivalent | INOVATIV, LLC |
| K013869 | SR IVOCRON | Aug 28, 2002 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K021457 | FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL | Aug 01, 2002 | Substantially Equivalent | PENTRON CORP. |
| K020178 | BELLEGLASS HP MODELING GEL | Mar 15, 2002 | Substantially Equivalent | KERR DENTAL MATERIALS CENTER |
| K020157 | TEMPORARY CROWN AND BRIDGE MATERIAL | Mar 04, 2002 | Substantially Equivalent | J. MORITA USA, INC. |
| K020092 | TEMPHASE | Feb 22, 2002 | Substantially Equivalent | KERR DENTAL MATERIALS CENTER |
| K013895 | TEMPFIL | Feb 04, 2002 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | Jan 24, 2002 | Substantially Equivalent | DMG USA, INC. |
| K012360 | LC TEMPORARY FILLING | Sep 06, 2001 | Substantially Equivalent | PARKELL, INC. |
| K010012 | LC PROVIFILL | Feb 14, 2001 | Substantially Equivalent | S & C POLYMER GMBH |
| K003817 | PATTERN RESIN | Jan 16, 2001 | Substantially Equivalent | GC AMERICA, INC. |
| K003377 | FERMIT N PLUS | Dec 04, 2000 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K003374 | FERMIT PLUS | Dec 04, 2000 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K001884 | DIRECT CROWN | Oct 25, 2000 | Substantially Equivalent | FLEXIBLE DIMENSIONS LLC. |
| K002364 | PROTEMP H | Aug 10, 2000 | Substantially Equivalent | ESPE DENTAL AG |
| K001309 | HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250 | Jun 13, 2000 | Substantially Equivalent | KAY SEE DENTAL MFG. CO. |
| K001114 | 3M QUIK TEMP TEMPORIZATION MATERIAL | Jun 09, 2000 | Substantially Equivalent | 3M COMPANY |
| K000894 | C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO | May 19, 2000 | Substantially Equivalent | DENTAL VENTURES OF AMERICA, INC. |
| K000346 | EZ CONNECT | Apr 14, 2000 | Substantially Equivalent | KERR DENTAL MATERIALS CENTER |
| K000951 | LUXAFORM | Apr 05, 2000 | Substantially Equivalent | DMG USA, INC. |
| K994012 | TEMPOFIT, MODEL 02693 | Feb 16, 2000 | Substantially Equivalent | DETAX GMBH & CO. KG |
| K991564 | JELTEMP | Jun 23, 1999 | Substantially Equivalent | J.F. JELENKO & CO., INC. |
| K991270 | SMARTEMP | May 21, 1999 | Substantially Equivalent | PARKELL, INC. |
| K980799 | HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL | Oct 28, 1998 | Substantially Equivalent | COSMEDENT, INC. |
| K982459 | TEMPFIL F - 2 | Sep 30, 1998 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K972198 | DENT-TEMP ACRYLIC | Dec 17, 1997 | Substantially Equivalent | HEALTH-DENT INTL., INC. |
| K970168 | 3M QUIKPLUS SYSTEM | Feb 27, 1997 | Substantially Equivalent | 3M COMPANY |
| K964981 | TEMPFIL C&B | Feb 10, 1997 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K964691 | TCB TEMPORARY CROWN AND BRIDGE MATERIAL | Feb 04, 1997 | Substantially Equivalent | SCICAN |
| K963786 | TEMPFIL F | Nov 19, 1996 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K961199 | BOSWORTH TEMPORARY RESIN | Jun 25, 1996 | Substantially Equivalent | HARRY J. BOSWORTH CO. |
| K961198 | BOSWORTH CH I | May 24, 1996 | Substantially Equivalent | HARRY J. BOSWORTH CO. |
| K954976 | POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION) | Apr 25, 1996 | Substantially Equivalent | HEALEX PRODUCTS, INC. |
| K960938 | PROV-KB | Apr 18, 1996 | Substantially Equivalent | SILICON-UND COMPOSITE SPEZIALITATEN GMBH |
| K960122 | ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL | Feb 21, 1996 | Substantially Equivalent | WALLACE A. ERICKSON & CO. |
| K955331 | BELLEGLASHP | Jan 02, 1996 | Substantially Equivalent | SYBRON DENTAL SPECIALTIES, INC. |
| K950203 | PROTEMP(R) GARANT | Feb 02, 1995 | Substantially Equivalent | ESPE GMBH & CO. KG. |
| K944981 | 3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM | Dec 02, 1994 | Substantially Equivalent | 3M COMPANY |
| K942670 | GC PATTERN RESIN | Oct 18, 1994 | Substantially Equivalent | GC AMERICA, INC. |
| K941849 | PROVIPONT C&B | Aug 17, 1994 | Substantially Equivalent | IVOCLAR USA, INC. |
| K924830 | LUXATEMP AUTOMIX | Apr 29, 1994 | Substantially Equivalent | DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH |
| K941124 | STRUCTUR 2 | Apr 13, 1994 | Substantially Equivalent | VOCO GMBH |
| K935960 | GC TEMPRON | Mar 04, 1994 | Substantially Equivalent | GC AMERICA, INC. |
| K935041 | 3M TEMPORARY CROWN & BRIDGE MATERIAL | Jan 26, 1994 | Substantially Equivalent | 3M COMPANY |
| K934978 | FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL | Dec 10, 1993 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K934283 | DENTALON PLUS MODIFICATION | Dec 10, 1993 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K932034 | PALAVIT 55 AND DENTACOLOR CONNECTOR | Aug 06, 1993 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K922559 | ACUFEX ENDOFIX BUTTON | Dec 24, 1992 | Substantially Equivalent | ACUFEX MICROSURGICAL, INC. |
| K915466 | SEPTOPACK TEMPORARY FILLING | Feb 03, 1992 | Substantially Equivalent | SPECIALITES SEPTODONT |
| K904251 | NEW TRIAD VLC CROWN & BRIDGE PROVISIONAL MATERIAL | Jun 06, 1991 | Substantially Equivalent | DENTIFAX INTERN, INC. |
| K903317 | DENTALON PLUS | Aug 13, 1990 | Substantially Equivalent | KULZER, INC. |
| K900389 | TEMPORARY CROWN MATRIX BUTTONS | Jul 13, 1990 | Substantially Equivalent | ADVANTAGE DENTAL PRODUCTS, INC. |
| K901077 | PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT) | May 29, 1990 | Substantially Equivalent | SCIENTIFIC PHARMACEUTICALS, INC. |
| K900068 | ARISTEE (RESIN, CROWN AND BRIDGES) | Apr 03, 1990 | Substantially Equivalent | PROMETEX, INC. |
| K900436 | PROTEMP II | Mar 28, 1990 | Substantially Equivalent | ESPE GMBH (US) |
| K892710 | ARISTEE (TEMPORARY CROWN & BRIDGE RESIN) | Oct 24, 1989 | Substantially Equivalent | PROMETEX, INC. |
| K890829 | UNIFAST LC | Apr 17, 1989 | Substantially Equivalent | G-C INTL. CORP. |
| K875133 | CAVIT-W | Mar 01, 1988 | Substantially Equivalent | ESPE GMBH (US) |
| K875145 | MAR BOND | Feb 26, 1988 | Substantially Equivalent | RELIANCE ORTHODONTIC PRODUCTS, INC. |
| K853092 | PSP C & B TEMP | Apr 03, 1986 | Substantially Equivalent | PSP DENTAL CO., LTD. |
| K853052 | INTEGRITY | Aug 16, 1985 | Substantially Equivalent | DENTSPLY INTL. |
| K833261 | INTERIM TEMP. CROWN & BRIDGE RESIN | Jan 03, 1984 | Substantially Equivalent | COE LABORATORIES, INC. |
| K831077 | DENTALON | Sep 12, 1983 | Substantially Equivalent | KULZER, INC. |
| K831294 | SOLARCRY/TEMPORARY CROWN & BRIDGE MAT | Aug 31, 1983 | Substantially Equivalent | SOLAR DENTAL CO., INC. |
| K822722 | CROWN S BRIDGE RESIN | Sep 30, 1982 | Substantially Equivalent | ROHM AND HAAS CO. |
| K822452 | PROTEMP | Sep 28, 1982 | Substantially Equivalent | ESPE GMBH (US) |
| K820456 | CROWN & BRIDGE RESIN FOR FABRICAT/DE | Mar 19, 1982 | Substantially Equivalent | ROHM AND HAAS CO. |
| K802679 | SILANIT | Dec 17, 1980 | Substantially Equivalent | VIVADENT (USA), INC. |
| K802489 | REIGNING CROWN BRIDGE | Nov 12, 1980 | Substantially Equivalent | OKI SHIKS USA LTD. |
| K800828 | MYERSON'S SPECIAL CROWN & BRIDGE RESIN | Apr 29, 1980 | Substantially Equivalent | MYERSON TOOTH CORP. |
| K781244 | TEMP. CROWN MSTERIAL FOR TEETH | Aug 31, 1978 | Substantially Equivalent | DEN-MAT CORP. |
| K772211 | TEMP. ACRYLIC | Dec 22, 1977 | Substantially Equivalent | LACTONG CORP. |
| K771602 | MYERSONS SPEC. CROWN & BRIDGE RESIN | Aug 30, 1977 | Substantially Equivalent | HOWMEDICA CORP. |
| K771530 | TEMP. CROWN ACRYLIC RESIN | Aug 25, 1977 | Substantially Equivalent | J. PALMERO SALES CO., INC. |
| K771527 | ACCU. CROWN COLD CURE | Aug 16, 1977 | Substantially Equivalent | PARKER LABORATORIES, INC. |
| K771257 | ACRY TEMP | Jul 15, 1977 | Substantially Equivalent | INTERSTATE DENTAL CO., INC. |
| K771254 | ACCU. CROWN COLD CURE | Jul 15, 1977 | Substantially Equivalent | BRIAR CLIFF, INC. |
FEI Numbers
This FDA classification entry is associated with 183 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 183 registration numbers. Click on an entry to view related FDA registrations.