Product Code: ELW FDA class 2 21 CFR 872.3660

Material, Impression

Dental

Dental Impression Material is a substance used to create an accurate negative reproduction of the oral structures, including teeth and surrounding soft tissues, that is subsequently poured with stone or plaster to produce a positive working cast used for fabricating dental restorations and appliances. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is ELW, regulated under 21 CFR 872.3660 in the Dental (DE) specialty. This device is eligible for third-party review.

View on FDA

510(k)s

400

FEI Numbers

147

Registration Numbers

147

Unique Applicants

175

Years Active

Basic Information

Product Code: ELW
Device Class: FDA class 2
Regulation Number: 872.3660
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

Related 510(k) Clearances

This FDA classification is associated with 400 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250969	JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST	Jun 27, 2025	Substantially Equivalent	Dent4You AG
K241924	Elastic Impression Material	Dec 27, 2024	Substantially Equivalent	Beijing OKVD Biological Technology Ltd.
K242360	Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator	Nov 15, 2024	Substantially Equivalent	Dent4You AG
K233954	Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu	Feb 13, 2024	Substantially Equivalent	B&E Korea Co., Ltd.
K223892	DentMix VPS Impression Material	Apr 27, 2023	Substantially Equivalent	Innovative Product Brands, Inc.
K213175	No Stress Impress	Jan 19, 2023	Substantially Equivalent	No Stress Impress LLC
K214086	Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty	Dec 15, 2022	Substantially Equivalent	Genoss Co., Ltd.
K222741	DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)	Nov 07, 2022	Substantially Equivalent	HDI, Inc.
K213244	Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)	Sep 09, 2022	Substantially Equivalent	Prevest Denpro Limited
K221668	Dental Impression Material	Aug 08, 2022	Substantially Equivalent	Chemoment Materials Co.,ltd
K213890	IMICRYL Impression Materials	Feb 11, 2022	Substantially Equivalent	IMICRYL Dis Malzemeleri San. Ve Tic. A.S.
K220257	Permadyne	Feb 01, 2022	Substantially Equivalent	3M Deutschland GmbH
K220097	PRESIDENT The Original	Jan 13, 2022	Substantially Equivalent	Coltène/Whaledent AG
K211489	Dental Impression Material	Jul 28, 2021	Substantially Equivalent	Nanchang Dental Bright Technology Co., Ltd
K203824	VPS Impression Material	Apr 19, 2021	Substantially Equivalent	Hygedent INC.
K210041	HySil Plus Impression Materials	Mar 18, 2021	Substantially Equivalent	Osstem Implant Co., Ltd.
K201483	Impression Material	Oct 08, 2020	Substantially Equivalent	Zhengzhou Huaer Electro Optics Technology Co., Ltd
K201684	A-Silicone for Bite Registration	Sep 24, 2020	Substantially Equivalent	Shandong Huge Dental Material Corporation
K201184	Lascod Impression Materials	May 05, 2020	Substantially Equivalent	Lascod Spa
K192941	HySil Super Fast Impression Materials	Jan 30, 2020	Substantially Equivalent	Osstem Implant Co., Ltd.
K190571	StoneBite and StoneBite scan	Nov 07, 2019	Substantially Equivalent	Dreve Dentamid GmbH
K191034	VPS Impression Material	Sep 04, 2019	Substantially Equivalent	Hygedent Inc.
K181604	Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite	Nov 28, 2018	Substantially Equivalent	HRS Co., Ltd.
K181236	HySil Impression Materials	Sep 13, 2018	Substantially Equivalent	OSSTEM IMPLANT CO LTD
K181011	AIM2	Jul 12, 2018	Substantially Equivalent	GC America Inc.
K180565	PEAK NS033CF, PEAK NS017CF	Jun 13, 2018	Substantially Equivalent	Neosil Co., Ltd
K171562	Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono	Apr 13, 2018	Substantially Equivalent	Dreve Dentamid GmbH
K173318	Rapid HB, Rapid LB, Rapid MB	Oct 31, 2017	Substantially Equivalent	3M Deutschland GmbH
K170812	HygePLUS Alginate Impression Material	Jul 26, 2017	Substantially Equivalent	HYGEDENT INC.
K170736	HySil Impression Materials	Jun 07, 2017	Substantially Equivalent	Osstem Implant Co., Ltd..
K152615	Vonflex S	Nov 03, 2016	Substantially Equivalent	VERICOM CO., LTD.
K161774	i-Sil	Sep 30, 2016	Substantially Equivalent	SPIDENT Co., Ltd.
K160097	Image Fast Set, Image Regular Set	Aug 05, 2016	Substantially Equivalent	Sybron Dental Specialties
K160441	Identic and KromaFaze Alginate Dental Impression Materials	Jun 30, 2016	Substantially Equivalent	KERR CORPORATION
K152826	NoCord	May 27, 2016	Substantially Equivalent	CENTRIX, INC.
K152766	CharmFlex	Mar 08, 2016	Substantially Equivalent	DENTKIST, INC
K152861	Aquasil Ultra + Smart Wetting Impression Material	Mar 04, 2016	Substantially Equivalent	DENTPLY INTERNATIONAL INC.
K152518	Vonflex S Putty	Nov 30, 2015	Substantially Equivalent	VERICOM CO., LTD
K152349	Star+ VPS Scannable Impression Material	Nov 23, 2015	Substantially Equivalent	DANVILLE MATERIALS LLC
K151535	Cavex Cream Alginate	Oct 28, 2015	Substantially Equivalent	CAVEX HOLLAND BV
K152180	PEAK	Oct 22, 2015	Substantially Equivalent	Neosil Co., Ltd
K151262	Hyflex Heavy, Hyflex Mono, Hyflex Light	Sep 21, 2015	Substantially Equivalent	Osstem Implant Co., Ltd
K151150	Elements	Jul 28, 2015	Substantially Equivalent	PAC-DENT INTERNATIONAL, INC.
K143575	Accu-Dent XD Tray, Accu-Dent XD Syringe	Apr 03, 2015	Substantially Equivalent	IVOCLAR VIVADENT, INC.
K143382	DentiAnn Smart Sil	Feb 23, 2015	Substantially Equivalent	SeilGlobal Co., Ltd.
K141092	MARK3	Dec 04, 2014	Substantially Equivalent	CAVEX HOLLAND B.V
K140966	VONFLEX S BITE	Aug 15, 2014	Substantially Equivalent	VERICOM CO., LTD.
K132869	SILDENT	Jun 19, 2014	Substantially Equivalent	HRS CO., LTD.
K140602	FLASH PENTA MB QUICK, FLASH MB QUICK	Jun 05, 2014	Substantially Equivalent	3M ESPE AG
K133071	ELASTIC IMPRESSION MATERIAL	May 28, 2014	Substantially Equivalent	RIZHAO HUGE DENTAL INDUSTRY CO., LTD
K140074	HYGEDENT ALGINATE IMPRESSION MATERIAL	May 21, 2014	Substantially Equivalent	HYGEDENT INC
K134008	MD-FLEX HEAVY BODY	Apr 09, 2014	Substantially Equivalent	META BIOMED, INC.
K133527	SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT	Mar 07, 2014	Substantially Equivalent	OSSTEM GERMANY GMBH
K133436	FLASH AR; FLASH AR QUICK	Mar 07, 2014	Substantially Equivalent	3M DEUTSCHLAND GMBH
K133400	FLASH BITE	Mar 06, 2014	Substantially Equivalent	3M ESPE AG
K132599	SMILEBOND SYSTEM	Feb 25, 2014	Substantially Equivalent	MILLENNIUM COMPANY LLC
K131510	POLYDIMETHYLSILOXANE IMPRESSION MATERIAL	Dec 20, 2013	Substantially Equivalent	BLACKWELL DEVICE CONSULTING
K130920	CORRECT PLUS 1	Jul 02, 2013	Substantially Equivalent	PENTRON CLINICAL
K131404	FLASH AR PENTA / FLASH AR PENTA QUICK	May 30, 2013	Substantially Equivalent	3M DEUTSCHLAND GMBH
K130869	TAKE 1 ADVANCE	May 30, 2013	Substantially Equivalent	SYBRON DENTAL SPECIALTIES
K130647	XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML	May 17, 2013	Substantially Equivalent	HERAEUS KULZER, LLC
K121824	ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2	Aug 23, 2012	Substantially Equivalent	LASCOD SPA
K120914	FLEXITIME FAST & SCAN LIGHT FLOW	Jul 25, 2012	Substantially Equivalent	HERAEUS KULZER, LLC
K113574	FLEXITIME MONOPHASE PRO SCAN	Jul 13, 2012	Substantially Equivalent	HERAEUS KULZER, LLC
K120013	TEMPSPAN CLEAR MATRIX	May 22, 2012	Substantially Equivalent	PENTRON CLINICAL
K120521	GC BLUE SILICONE	May 10, 2012	Substantially Equivalent	GC AMERICA, INC.
K120438	FLASH (DIFFERENT MATERIALS)	May 02, 2012	Substantially Equivalent	3M DEUTSCHLAND GMBH
K113406	AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL	Feb 13, 2012	Substantially Equivalent	DENTSPLY INTERNATIONAL, INC.
K113279	IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT	Nov 14, 2011	Substantially Equivalent	KETTENBACH GMBH & CO KG
K113263	ARGES IMAGING CONTRAST SPRAY	Nov 14, 2011	Substantially Equivalent	ARGES IMAGING, INC
K110871	FIT CHECKER ADVANCED	Jun 17, 2011	Substantially Equivalent	GC AMERICA, INC.
K110092	TAKE 1 ADVANCED RIGID TRAY	Apr 08, 2011	Substantially Equivalent	KERR CORPORATION
K110378	IMPRESSION COMPOUND	Apr 05, 2011	Substantially Equivalent	SPOFADENTAL
K103586	IOS FASTSCAN SPRAY	Mar 30, 2011	Substantially Equivalent	IOS TECHNNOLOGIES, INC.
K110050	FIT TEST C&B	Mar 28, 2011	Substantially Equivalent	VOCO GMBH
K103346	DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY	Feb 11, 2011	Substantially Equivalent	SHERPA KOREA
K102836	BONASIL A+ IMPRESSION MATERIALS	Jan 13, 2011	Substantially Equivalent	DMP LTD
K102770	FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW	Dec 21, 2010	Substantially Equivalent	HERAEUS KULZER, LLC
K102739	HYDROCOLOR 5	Dec 08, 2010	Substantially Equivalent	CASCADES DEVICE CONSULTING ASSOCIATES
K103164	VONFLEX HEAVY, VINFLEX LIGHT	Nov 10, 2010	Substantially Equivalent	VERICOM CO., LTD.
K101617	FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL	Sep 07, 2010	Substantially Equivalent	HERAEUS KULZER, LLC
K092176	TAKE 1 ADVANCED RIGID TRAY	Jan 28, 2010	Substantially Equivalent	KERR CORPORATION
K091613	TAKE 1	Oct 07, 2009	Substantially Equivalent	KERR CORP.
K092867	IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT	Oct 01, 2009	Substantially Equivalent	KETTENBACH GMBH & CO KG
K092319	STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387	Sep 16, 2009	Substantially Equivalent	DANVILLE MATERIALS, INC.
K091494	FLEXITIME FLOW	Jul 31, 2009	Substantially Equivalent	HERAEUS KULZER, INC.
K091267	VONFLEX PUTTY	May 06, 2009	Substantially Equivalent	VERICOM CO., LTD.
K083739	HYDRORISE AND HYDROSYSTEM	Mar 26, 2009	Substantially Equivalent	ZHERMACK S.P.A.
K083701	PANASIL INITIAL CONTACT AND PANASIL TRAY	Jan 09, 2009	Substantially Equivalent	KETTENBACH GMBH & CO KG
K082591	FLEXITIME BITE	Dec 05, 2008	Substantially Equivalent	HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION
K082560	PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT	Sep 08, 2008	Substantially Equivalent	KETTENBACH GMBH & CO KG
K082157	KETTOSIL AND SILGINAT	Aug 06, 2008	Substantially Equivalent	KETTENBACH GMBH & CO KG
K081017	TEMPLATE AND COUNTER-FIT	Aug 04, 2008	Substantially Equivalent	CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
K081084	COLORISE RIGID	May 14, 2008	Substantially Equivalent	ZHERMACK S.P.A.
K081120	FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS	May 01, 2008	Substantially Equivalent	KETTENBACH GMBH & CO KG
K080338	CUTTERSIL ACTIVATOR UNIVERSAL PLUS	Apr 21, 2008	Substantially Equivalent	HERAEUS KULZER GMBH
K080882	CEREC OPTI SPRAY	Apr 11, 2008	Substantially Equivalent	SIRONA DENTAL SYSTEMS GMBH
K080514	PECD-01 AND PECD QUICK-01	Mar 26, 2008	Substantially Equivalent	3M ESPE AG DENTAL PRODUCTS
K080130	OCCLUFAST CAD	Mar 14, 2008	Substantially Equivalent	ZHERMACK S.P.A.
K073475	SYSTEM PLUS	Mar 10, 2008	Substantially Equivalent	CONTINENTAL DENTAL LABORATORY
K073005	ELITE GLASS	Dec 12, 2007	Substantially Equivalent	ZHERMACK S.P.A.
K072577	BISICO IMPRESSION SILICONES & ALGINATES	Dec 05, 2007	Substantially Equivalent	BISICO GMBH & CO KG
K072622	STANDOUT 2	Dec 04, 2007	Substantially Equivalent	KERR CORP.
K072245	EMULATE ADVANCED	Nov 08, 2007	Substantially Equivalent	CAVEX HOLLAND B.V.
K071192	BLUGOO HD	Jun 22, 2007	Substantially Equivalent	LANCER ORTHODONTICS, INC.
K070677	COLORISE	May 11, 2007	Substantially Equivalent	ZHERMACK S.P.A.
K070700	FREEALGIN	Apr 25, 2007	Substantially Equivalent	ZHERMACK S.P.A.
K062400	IMPRESSIX, COLORCHANGE ALGINATE	Nov 16, 2006	Substantially Equivalent	CAVEX HOLLAND B.V.
K060891	VIRTUAL	Jul 17, 2006	Substantially Equivalent	IVOCLAR VIVADENT, INC.
K061267	SIMULATE, COLOR CHANGE ALGINATE	Jul 10, 2006	Substantially Equivalent	CAVEX HOLLAND B.V.
K061427	PRE-IMPRESSION CONDITIONING SOLUTION	Jun 26, 2006	Substantially Equivalent	DENTSPLY INTL.
K053619	COLORBITE	Mar 01, 2006	Substantially Equivalent	ZHERMACK S.P.A.
K053427	FRESH, DENTAL IMPRESSION MATERIAL	Jan 13, 2006	Substantially Equivalent	EXACTA DENTAL PRODUCTS, INC.
K051933	EXPASYL POWER APPLICATOR	Jan 03, 2006	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K052455	IMPRESSIX	Nov 23, 2005	Substantially Equivalent	CAVEX HOLLAND B.V.
K053014	POLY SILOXANE IMPRESSION MATERIAL	Nov 15, 2005	Substantially Equivalent	CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
K053018	POLY SILOXANE IMPRESSION MATERIAL	Nov 08, 2005	Substantially Equivalent	MILLENNIUM DENTAL INTERNATIONAL, INC.
K052409	SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL	Oct 20, 2005	Substantially Equivalent	SULTAN CHEMISTS, INC.
K052090	SPLASH! IMPRESSION MATERIAL DEVICE	Aug 05, 2005	Substantially Equivalent	DISCUS DENTAL INC.
K051797	FUTURE WASH/YPS	Jul 21, 2005	Substantially Equivalent	3M ESPE AG DENTAL PRODUCTS
K050417	ELITE IMPLANT	Jul 19, 2005	Substantially Equivalent	ZHERMACK S.P.A.
K051424	HYDROGUM 5	Jul 15, 2005	Substantially Equivalent	ZHERMACK S.P.A.
K051535	MODIFICATION TO:REGISTRADO X-TRA	Jun 28, 2005	Substantially Equivalent	VOCO GMBH
K051243	JET BLUE BITE	Jun 23, 2005	Substantially Equivalent	COLTENE/WHALEDENT AG
K051207	CAVEX ORTHOTRACE	Jun 21, 2005	Substantially Equivalent	CAVEX HOLLAND B.V.
K050604	KERR VPS IMPRESSION MATERIAL	Apr 15, 2005	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K043493	FUSION PUTTY TYPE	Mar 04, 2005	Substantially Equivalent	GC AMERICA, INC.
K043054	GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL	Feb 18, 2005	Substantially Equivalent	SULTAN CHEMISTS, INC.
K050013	RETRACTOFOAM	Feb 09, 2005	Substantially Equivalent	COLTENE/WHALEDENT AG
K043471	FUSION FAST	Jan 27, 2005	Substantially Equivalent	GC AMERICA, INC.
K043118	HYDROGUM SOFT	Jan 24, 2005	Substantially Equivalent	ZHERMACK S.P.A.
K042878	FLEXITIME XTREME	Dec 17, 2004	Substantially Equivalent	HERAEUS KULZER, INC.
K043131	TORPICALGIN	Dec 15, 2004	Substantially Equivalent	ZHERMACK S.P.A.
K042860	CORRECT DENTAL IMPRESSION MATERIAL	Dec 03, 2004	Substantially Equivalent	HANDAE CHEMICAL CO., LTD.
K041398	GC FUSION	Jun 25, 2004	Substantially Equivalent	GC AMERICA, INC.
K041229	MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)	Jun 17, 2004	Substantially Equivalent	COSMEDENT, INC.
K041028	CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL	May 14, 2004	Substantially Equivalent	CROWN DELTA CORP.
K040053	PRECISION VPS IMPRESSION MATERIAL	Mar 25, 2004	Substantially Equivalent	DISCUS DENTAL INC.
K032708	PLASTALGIN AND PLASTALGIN ORTHO	Nov 20, 2003	Substantially Equivalent	SEPTODONT
K032289	FIT CHECKER II	Oct 20, 2003	Substantially Equivalent	GC AMERICA, INC.
K031439	ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)	Oct 02, 2003	Substantially Equivalent	HARRY J. BOSWORTH CO.
K032116	TULIP COLORSWITCH	Sep 30, 2003	Substantially Equivalent	CAVEX HOLLAND B.V.
K032001	POLY Q (GARANT L, PENTA M, PENTA H)	Aug 11, 2003	Substantially Equivalent	3M ESPE AG DENTAL PRODUCTS
K031484	STAND OUT	Jul 03, 2003	Substantially Equivalent	KERR CORP.
K030776	MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL	May 09, 2003	Substantially Equivalent	DISCUS DENTAL, INC.
K030414	GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL	Apr 09, 2003	Substantially Equivalent	SULTAN CHEMISTS, INC.
K030318	P2 POLYETHER	Apr 03, 2003	Substantially Equivalent	HERAEUS KULZER, INC.
K023751	EXAJET	Jan 22, 2003	Substantially Equivalent	GC AMERICA, INC.
K024041	ZETAPLUS SOFT	Dec 18, 2002	Substantially Equivalent	ZHERMACK S.P.A.
K024034	OCCLUFAST ROCK	Dec 18, 2002	Substantially Equivalent	ZHERMACK S.P.A.
K023466	TULIP ALGINATE IMPRESSION MATERIAL	Dec 13, 2002	Substantially Equivalent	CAVEX HOLLAND B.V.
K022653	ELITE MONOPHASE	Oct 28, 2002	Substantially Equivalent	ZHERMACK S.P.A.
K022430	ISO FUNCTIONAL	Oct 18, 2002	Substantially Equivalent	GC AMERICA, INC.
K022066	REGISTRADO X-TRA	Aug 14, 2002	Substantially Equivalent	VOCO GMBH
K021416	AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL	May 13, 2002	Substantially Equivalent	DENTSPLY INTL.
K021413	AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL	May 10, 2002	Substantially Equivalent	DENTSPLY INTL.
K021410	AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL	May 08, 2002	Substantially Equivalent	DENTSPLY INTL.
K020242	EMULATE FAST SET AND EMULATE REGULAR SET	Apr 17, 2002	Substantially Equivalent	CAVEX HOLLAND B.V.
K013859	RHODIA BITE REGISTRATION MATERIAL	Jan 29, 2002	Substantially Equivalent	RHODIA INC.
K012767	S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL	Nov 01, 2001	Substantially Equivalent	S & C POLYMER GMBH
K012517	CEREC3 VITABLOCKS	Nov 01, 2001	Substantially Equivalent	SIRONA DENTAL SYSTEMS GMBH
K013336	XANTALGIN CRONO	Oct 29, 2001	Substantially Equivalent	CAVEX HOLLAND B.V.
K013237	STATUSBLUE	Oct 22, 2001	Substantially Equivalent	DMG USA, INC.
K013236	LUXABITE	Oct 17, 2001	Substantially Equivalent	DMG USA, INC.
K013140	RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL	Oct 10, 2001	Substantially Equivalent	RHODIA INC.
K013129	RHODIA DENTAL PUTTY IMPRESSION MATERIAL	Oct 10, 2001	Substantially Equivalent	RHODIA INC.
K012405	EXTRUDE MODIFIED	Sep 04, 2001	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K011785	NOVEL PRINT CYAN ALGINATES	Sep 04, 2001	Substantially Equivalent	MANUFACTURERA DENTAL CONTINENTAL
K011452	CAVEX STABISIL	Jul 19, 2001	Substantially Equivalent	CAVEX HOLLAND B.V.
K011419	CAVEX COLORCHANGE	Jul 16, 2001	Substantially Equivalent	CAVEX HOLLAND B.V.
K011450	SILICONE IMPRESSION MATERIAL	Jun 13, 2001	Substantially Equivalent	NORTHEAST RESINS & SILICONES, LLC.
K010994	TAKE ONE BITE MODIFIED	Apr 23, 2001	Substantially Equivalent	KERR CORP.
K010926	R-SI-LINE METAL-BITE	Apr 12, 2001	Substantially Equivalent	R-DENTAL DENTALERZEUGNISSE GMBH
K003808	TAKE 1	Mar 01, 2001	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K003650	PERMLASTIC 3	Feb 15, 2001	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K003930	FLEXTIME MAGNUM 360	Feb 01, 2001	Substantially Equivalent	HERAEUS KULZER, INC.
K003426	ALGINATE IMPRESSION MATERIAL	Jan 23, 2001	Substantially Equivalent	RITE-DENT MANUFACTURING CORP.
K001655	PERMLASTIC 2	Aug 10, 2000	Substantially Equivalent	KERR CORP.
K001414	KWIKKMODEL	Aug 09, 2000	Substantially Equivalent	R-DENTAL DENTALERZEUGNISSE GMBH
K001876	TAKE 1 BITE	Jul 21, 2000	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K001218	CORRECT PLUS	Jul 05, 2000	Substantially Equivalent	JENERIC/PENTRON, INC.
K000686	KROM-ALGINATE AND ALGINATE PLUS	May 25, 2000	Substantially Equivalent	CAVEX HOLLAND B.V.
K994027	ACTIVATOR PASTE	Apr 13, 2000	Substantially Equivalent	HARRY J. BOSWORTH CO.
K000878	HONIGUM	Apr 11, 2000	Substantially Equivalent	DMG USA, INC.
K000629	FLEXTIME	Apr 05, 2000	Substantially Equivalent	HERAEUS KULZER, INC.
K000595	DIMENSION PENTA L	Apr 05, 2000	Substantially Equivalent	ESPE DENTAL AG
K000591	DIMENSION PENTA H, DIMENSION PENTA H QUICK	Mar 30, 2000	Substantially Equivalent	ESPE DENTAL AG
K000588	DIMENSION GARANT L, DIMENSION GARANT L QUICK	Mar 30, 2000	Substantially Equivalent	ESPE DENTAL AG
K994172	CEREC 3	Feb 08, 2000	Substantially Equivalent	SIRONA DENTAL SYSTEMS GMBH
K994193	IMPREGUM PENTA DUOSOFT	Jan 28, 2000	Substantially Equivalent	ESPE DENTAL AG
K994192	IMPREGUM PENTA M MONOSOFT	Jan 28, 2000	Substantially Equivalent	ESPE DENTAL AG
K994190	IMPREGUM GARANT L DUOSOFT	Jan 27, 2000	Substantially Equivalent	ESPE DENTAL AG
K994077	AROMA FINE (NORMAL AND FAST SET)	Jan 27, 2000	Substantially Equivalent	GC AMERICA, INC.
K992001	TRAY-LINK	Nov 02, 1999	Substantially Equivalent	SILICON-UND COMPOSITE SPEZIALITATEN GMBH
K992897	IMPREGUM PENTA	Sep 08, 1999	Substantially Equivalent	ESPE DENTAL AG
K992895	IMPREGUM F	Sep 08, 1999	Substantially Equivalent	ESPE DENTAL AG
K991631	FASTRAY LC	Jul 26, 1999	Substantially Equivalent	HARRY J. BOSWORTH CO.
K991490	ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)	Jul 15, 1999	Substantially Equivalent	HARRY J. BOSWORTH CO.
K991489	ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET)	Jul 15, 1999	Substantially Equivalent	HARRY J. BOSWORTH CO.
K991008	DIMENSION BITE	Jun 18, 1999	Substantially Equivalent	ESPE DENTAL AG
K991425	XANTOPREN COMFORT	Jun 15, 1999	Substantially Equivalent	HERAEUS KULZER, INC.
K991221	VESTOGUM	May 20, 1999	Substantially Equivalent	ESPE DENTAL AG
K983106	1ST IMPRESSION	Feb 09, 1999	Substantially Equivalent	DEN-MAT CORP.
K982917	B-SYSTEM SILICONE	Oct 16, 1998	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K981970	ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXI	Sep 02, 1998	Substantially Equivalent	CAVEX HOLLAND B.V.
K981325	3M M.G. MATERIAL	Jun 11, 1998	Substantially Equivalent	3M COMPANY
K980968	LONE STAR IMPRESSION SYSTEMS	Jun 09, 1998	Substantially Equivalent	LONE STAR TECHNOLOGIES
K981091	NEOCOLLOID, ORTHOPRINT	May 21, 1998	Substantially Equivalent	ZHERMACK S.P.A.
K980963	HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)	May 11, 1998	Substantially Equivalent	FOREMOST DENTAL MFG., INC.
K980965	SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL	May 01, 1998	Substantially Equivalent	CAVEX HOLLAND B.V.
K974894	KROMATICA COLOR CHANGING ALGINATE	Feb 12, 1998	Substantially Equivalent	MATECH, INC.
K974704	HYDROGUM	Jan 29, 1998	Substantially Equivalent	ZHERMACK S.P.A.
K974231	POSITION PENTA, POSITION PENTA QUICK	Jan 29, 1998	Substantially Equivalent	ESPE GMBH & CO. KG.
K973781	AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL	Dec 11, 1997	Substantially Equivalent	DENTSPLY INTL.
K973782	AQUASIL XLV SMART WETTING IMPRESSION MATERIAL	Dec 04, 1997	Substantially Equivalent	DENTSPLY INTL.
K973694	PROVIL NOVO	Nov 24, 1997	Substantially Equivalent	HERAEUS KULZER, INC.
K973343	HYDROFLEX	Oct 21, 1997	Substantially Equivalent	GC AMERICA, INC.
K972871	GENESIS	Oct 02, 1997	Substantially Equivalent	PACIFIC RIM DENTAL, INC.
K970129	TULIP	Aug 18, 1997	Substantially Equivalent	RICHARD TING
K972276	CEREC 2 CROWN SOFTWARE	Aug 15, 1997	Substantially Equivalent	SIEMENS AG
K972239	ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING	Aug 01, 1997	Substantially Equivalent	ZHERMACK S.P.A.
K972027	ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)	Jul 16, 1997	Substantially Equivalent	ZHERMACK S.P.A.
K971155	MEMOREG	May 22, 1997	Substantially Equivalent	HERAEUS KULZER, INC.
K970656	HYDROFLEX	Apr 08, 1997	Substantially Equivalent	GC AMERICA, INC.
K965083	SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET	Apr 04, 1997	Substantially Equivalent	S.S. WHITE MFG., LTD.
K970594	KALGINATE IMPRESSION MATERIAL	Mar 31, 1997	Substantially Equivalent	TELEDYNE WATER PIK
K970433	AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL	Mar 27, 1997	Substantially Equivalent	DENTSPLY INTL.
K965165	CUTTERSIL COMFORT HARDENER	Mar 19, 1997	Substantially Equivalent	HERAEUS KULZER, INC.
K965163	CUTTERSIL COMFORT	Mar 19, 1997	Substantially Equivalent	HERAEUS KULZER, INC.
K964692	PERFECTIM	Feb 25, 1997	Substantially Equivalent	J. MORITA USA, INC.
K964177	KROMALGIN IMPRESSION MATERIAL	Dec 30, 1996	Substantially Equivalent	NORTH AMERICAN ORTHODONTIC LABORATORIES, INC.
K964323	CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL	Dec 16, 1996	Substantially Equivalent	FEN DENTAL MFG., INC.
K963609	PHASE PLUS	Nov 14, 1996	Substantially Equivalent	ZHERMACK S.P.A.
K963766	3M PROPLUS SYSTEM	Oct 31, 1996	Substantially Equivalent	3M COMPANY
K963205	ALGINMAX, ORTHOCHROME	Oct 29, 1996	Substantially Equivalent	AMERICAN TOOTH INDUSTRIES
K962680	HYUNJAE DENTAL IMPRESSION MATERIALS	Sep 30, 1996	Substantially Equivalent	HYUNJAE CORP.
K962741	TRI-PHASIX CHROMATIC ALGINATE	Sep 06, 1996	Substantially Equivalent	PARKELL, INC.
K952614	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	Aug 13, 1996	Substantially Equivalent	DENTSPLY INTL.
K954281	PANASIL IMPRESSION MATERIAL	Jun 24, 1996	Substantially Equivalent	ROYDENT DENTAL PRODUCTS, INC.
K961201	BOSWORTH IMPRESSION MATERIAL II	May 17, 1996	Substantially Equivalent	HARRY J. BOSWORTH CO.
K960547	DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE	Mar 15, 1996	Substantially Equivalent	ESPE GMBH & CO. KG.
K955932	EXAFLEX IMPRESSION MATERIAL (MODIFICATION)	Mar 11, 1996	Substantially Equivalent	GC AMERICA, INC.
K955892	HYDROCOLLOID TRAY MATERIALS, MED. TO HIGH VISCOSITY/WASH MATERIALS, LOW VISCOSITY	Mar 05, 1996	Substantially Equivalent	VAN R DENTAL PRODUCTS, INC.
K960063	BOSWORTH IMPRESSION MATERIAL I	Feb 14, 1996	Substantially Equivalent	HARRY J. BOSWORTH CO.
K955465	DEGUPRINT	Dec 28, 1995	Substantially Equivalent	DEGUSSA CORP.
K955406	SCAN WHITE 12 ML	Dec 28, 1995	Substantially Equivalent	VIDENT
K954192	IMPREGUM PENTA	Dec 01, 1995	Substantially Equivalent	ESPE GMBH & CO. KG.
K954180	MICROGLISS	Nov 21, 1995	Substantially Equivalent	ESPE GMBH & CO. KG.
K954662	THERMALASTIC/TRIPOLYVINALENE	Nov 15, 1995	Substantially Equivalent	TAK SYSTEMS
K935892	INDURENT GEL	Oct 17, 1995	Substantially Equivalent	ZHERMACK DENTAL PRODUCTION
K954223	AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING	Sep 29, 1995	Substantially Equivalent	AMERICAN DENTAL PRODUCTS, INC.
K952728	RETRAC	Sep 29, 1995	Substantially Equivalent	CENTRIX, INC.
K952930	DENTRAY II PLUS TRAY ADHESIVE	Sep 08, 1995	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K935890	ZETAPLUS (PUTTY)	Sep 08, 1995	Substantially Equivalent	ZHERMACK DENTAL PRODUCTION
K952422	ELASTIC IMPRESSION CREAM	Aug 29, 1995	Substantially Equivalent	TELEDYNE WATER PIK
K935898	HYDROGUM	Aug 22, 1995	Substantially Equivalent	ZHERMACK DENTAL PRODUCTION
K953374	PERMADYNE GARANT 2:1	Aug 18, 1995	Substantially Equivalent	ESPE GMBH & CO. KG.
K952693	RAMITEC PENTA	Aug 18, 1995	Substantially Equivalent	ESPE GMBH & CO. KG.
K953027	PERMADYNE PENTA (HIGH & LOW VISCOSITY)	Jul 19, 1995	Substantially Equivalent	ESPE GMBH & CO. KG.
K950299	CEREC 2	May 23, 1995	Substantially Equivalent	PELTON & CRANE CO.
K951237	ALGI-BAND	Apr 10, 1995	Substantially Equivalent	HEALTH-DENT INTL., INC.
K951075	S & C VINYL POLYSILOXANE IMPRESSION MATERIAL	Mar 31, 1995	Substantially Equivalent	S & C POLYMER GMBH
K945142	POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)	Jan 11, 1995	Substantially Equivalent	SCICAN
K943388	GC SURFLEX F	Sep 12, 1994	Substantially Equivalent	GC AMERICA, INC.
K935896	THIXOFLEX	Sep 09, 1994	Substantially Equivalent	ZHERMACK DENTAL PRODUCTION
K943574	CAPTURE IMPRESSION MATERIAL	Aug 23, 1994	Substantially Equivalent	DENTSPLY INTL.
K935889	OCCLUFAST	Aug 23, 1994	Substantially Equivalent	ZHERMACK DENTAL PRODUCTION
K935888	ELITE FAST LIGHT BODY	Aug 23, 1994	Substantially Equivalent	ZHERMACK DENTAL PRODUCTION
K935887	ELITE REGULAR BODY	Aug 23, 1994	Substantially Equivalent	ZHERMACK DENTAL PRODUCTION
K935886	ELITE LIGHT BODY	Aug 23, 1994	Substantially Equivalent	ZHERMACK DENTAL PRODUCTION
K935885	ELITE FAST PUTTY SOFT	Aug 23, 1994	Substantially Equivalent	ZHERMACK DENTAL PRODUCTION
K935884	ELITE PUTTY SOFT	Aug 23, 1994	Substantially Equivalent	ZHERMACK DENTAL PRODUCTION
K931242	ELITE PUTTY HARD	Aug 23, 1994	Substantially Equivalent	ZHERMACK DENTAL PRODUCTION
K943475	ULTRA HYDROPHILIC ALGINAE	Aug 12, 1994	Substantially Equivalent	ESSENTIAL DENTAL SYSTEMS, INC.
K942219	ALGIDENCO AND ALGIPRINT IMPRESSION MATERIALS	Aug 12, 1994	Substantially Equivalent	ROBERT W. BAUER & ASSOC., INC.
K942666	ORTHALGENAT IMPRESSION MATERIAL	Aug 10, 1994	Substantially Equivalent	DENTAURAUM, INC.
K940860	CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS	May 27, 1994	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K940685	PRETREATMENT SOLUTION	Apr 28, 1994	Substantially Equivalent	DENTSPLY INTL.
K935151	HYDROCOLLOID HEATING UNIT	Apr 04, 1994	Substantially Equivalent	CENTRIX, INC.
K940402	SUPERGEL/SUPPRESSED DUST	Mar 28, 1994	Substantially Equivalent	HARRY J. BOSWORTH CO.
K940379	EXTRUDE	Mar 22, 1994	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K940120	ALPHA-DENT	Feb 25, 1994	Substantially Equivalent	WALLACE A. ERICKSON & CO.
K936070	TREND SET 2 PLUS	Feb 04, 1994	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K925746	REPLICA	Jan 21, 1994	Substantially Equivalent	MATECH, INC.
K930248	VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM	Jan 07, 1994	Substantially Equivalent	CROWN DELTA CORP.
K933206	EXA BITE REGISTRATION MATERIAL	Sep 29, 1993	Substantially Equivalent	GC AMERICA, INC.
K921571	1ST IMPRESSION	Sep 10, 1993	Substantially Equivalent	WYKLE RESEARCH, INC.
K932459	FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL	Aug 09, 1993	Substantially Equivalent	3M COMPANY
K926033	VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD	May 05, 1993	Substantially Equivalent	HARRY J. BOSWORTH CO.
K925370	TRIANGULAR JAW MICROLARYNGEAL FORCEPS	Mar 18, 1993	Substantially Equivalent	PILLING CO.
K923202	Q3 (LIGHT AND UNIVERSAL) IMPRESSION MATERIAL	Aug 27, 1992	Substantially Equivalent	JENERIC/PENTRON, INC.
K914178	CORRECTED-V.P.S.	Apr 28, 1992	Substantially Equivalent	JENERIC/PENTRON, INC.
K914437	CORRECT-S.I.M.	Jan 17, 1992	Substantially Equivalent	JENERIC/PENTRON, INC.
K895901	VITA CEREC SET AND VITA CEREC BLOCS	Jan 17, 1992	Substantially Equivalent	VIDENT
K912001	CONVERTRAY, MODIFICATION	Jan 09, 1992	Substantially Equivalent	WILDE DENTAL (USA)
K913583	CONVERSIL FL AND CONVERSIL P	Nov 13, 1991	Substantially Equivalent	WILDE-USA, INC.
K913537	MEMOSIL C.D.	Oct 04, 1991	Substantially Equivalent	HERAEUS KULZER, INC.
K912485	COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC	Jul 25, 1991	Substantially Equivalent	COLTENE/WHALEDENT INC.
K910360	CUTTERSIL FUNCTION ACTIVATOR	Jun 06, 1991	Substantially Equivalent	HERAEUS KULZER, INC.
K910189	PERFOURM PUTTY SOFT	Jun 06, 1991	Substantially Equivalent	HERAEUS KULZER, INC.
K910166	CUTTERSIL XL	Jun 06, 1991	Substantially Equivalent	HERAEUS KULZER, INC.
K910165	CUTTERSIL MUCOSA	Jun 06, 1991	Substantially Equivalent	HERAEUS KULZER, INC.
K905032	MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL	Mar 15, 1991	Substantially Equivalent	PARKELL
K904927	HENNSON INTERNATIONAL DENTAL CAD/CAM SYSTEM	Dec 28, 1990	Substantially Equivalent	HENNSON INTL., INC.
K904482	STAT.BR TM	Nov 29, 1990	Substantially Equivalent	KERR CORPORATION (DANBURY)
K903292	ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS	Oct 19, 1990	Substantially Equivalent	COE LABORATORIES, INC.
K901866	DEGUFLEX (R) CS LIGHT	Sep 07, 1990	Substantially Equivalent	DEGUSSA AG
K901867	DEGUFLEX (R) CS PUTTY	Sep 06, 1990	Substantially Equivalent	DEGUSSA AG
K901865	DEGUFLEX MONOPHASE	Sep 06, 1990	Substantially Equivalent	DEGUSSA AG
K901681	FORMASIL(R)A POLYVINYL SILOXANE LINE	Jun 15, 1990	Substantially Equivalent	KULZER, INC.
K896468	EOS BLUEPHASE-P AND REDPHASE-P IMPRESSION MATERIAL	Apr 30, 1990	Substantially Equivalent	IVOCLAR NORTH AMERICA, INC.
K896786	ZONAREX FINAL IMPRESSION COMPOUND	Apr 19, 1990	Substantially Equivalent	CRAFT DENTAL LABORATORY, INC.
K896785	ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/	Apr 19, 1990	Substantially Equivalent	CRAFT DENTAL LABORATORY, INC.
K896539	PERMADYNE GARANT LOW VISCOSITY	Feb 09, 1990	Substantially Equivalent	ESPE GMBH (US)
K894282	FIRST IMPRESSION TM	Dec 22, 1989	Substantially Equivalent	COE LABORATORIES, INC.
K892412	POLYETHER-RETARDER	Dec 04, 1989	Substantially Equivalent	ESPE GMBH (US)
K892839	PALGARAPID	Oct 27, 1989	Substantially Equivalent	ESPE GMBH (US)
K894281	FIRST IMPRESSION WITH CHLORHEXIDINE	Sep 26, 1989	Substantially Equivalent	COE LABORATORIES, INC.
K890449	PERMAGUM PUTTY SOFT & PERMAGUM GARRANT	Jul 27, 1989	Substantially Equivalent	WACKER-CHEMIE GMBH
K892935	RESOUND IMPRESSION MATERIAL	Jul 14, 1989	Substantially Equivalent	RESOUND CORP.
K884166	DICOR CERAMIC INLAY - NEW TECHNIC	Apr 17, 1989	Substantially Equivalent	DENTSPLY INTL.
K883842	DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.	Mar 17, 1989	Substantially Equivalent	DENTSPLY INTL.
K884381	PALGAFLEX AND PALGAFLEX-QUICK	Jan 04, 1989	Substantially Equivalent	ESPE GMBH (US)
K882800	COLTENE PRESIDENT JET REGULAR BODY	Sep 23, 1988	Substantially Equivalent	COLTENE, INC.
K882690	IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL	Aug 11, 1988	Substantially Equivalent	3M COMPANY
K881091	OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL	Jun 28, 1988	Substantially Equivalent	COE LABORATORIES, INC.
K872745	VINYL POLYSILOXANE IMPRESSION SYSTEM	Jul 21, 1987	Substantially Equivalent	CROWN DELTA CORP.
K871409	VINYL POLYSILOXANE IMPRESSION SYSTEM	Jun 11, 1987	Substantially Equivalent	CROWN DELTA CORP.
K870011	CONTRASYL IMPRESSION MATERIAL	Mar 19, 1987	Substantially Equivalent	CONTRACAP
K870047	COLTENE RAPID	Jan 29, 1987	Substantially Equivalent	COLTENE, INC.
K863288	HYDROPHILIC REPROSIL	Dec 01, 1986	Substantially Equivalent	DENTSPLY INTL.
K862879	NEW LIGHT-CURING IMPRESSION MATERIAL	Sep 25, 1986	Substantially Equivalent	DENTSPLY INTL.
K860855	SHUR GEL 4	Jun 16, 1986	Substantially Equivalent	COLUMBUS DENTAL MFG. CO.
K853089	SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE	Apr 21, 1986	Substantially Equivalent	PSP DENTAL CO., LTD.
K860911	AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL	Mar 26, 1986	Substantially Equivalent	AUSTENAL DENTAL, INC.
K860532	KERR POL-E-LASTIC DENTAL IMPRESSION MATERIAL	Mar 20, 1986	Substantially Equivalent	KERR CORPORATION (DANBURY)
K860146	POLYJEL N.F. (NEW FORMULA)	Mar 17, 1986	Substantially Equivalent	DENTSPLY INTL.
K854106	BAYSILEX	Mar 17, 1986	Substantially Equivalent	CUTTER LABORATORIES, INC.
K853529	IMPREGUM-F	Mar 17, 1986	Substantially Equivalent	ESPE GMBH (US)
K855112	DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS	Mar 06, 1986	Substantially Equivalent	PACIFIC UNION DENTAL, INC.
K855111	DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES	Mar 06, 1986	Substantially Equivalent	PACIFIC UNION DENTAL, INC.
K854855	PROOF ALGINATE IMPRESSION MATERIAL	Jan 30, 1986	Substantially Equivalent	SYBRON CORP.
K844446	BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.	Oct 29, 1985	Substantially Equivalent	PULPDENT CORP. OF AMERICA
K851388	SEPTOSIL SILICONE FOR PRECISION IMPRESSION	May 29, 1985	Substantially Equivalent	SPECIALITES SEPTODONT
K851469	76 ELW BITE CHECKER SILICONE	May 01, 1985	Substantially Equivalent	G-C INTL. CORP.
K842877	ABSOLUTE VINYL POLYSILOXANE IMPRESS	Mar 11, 1985	Substantially Equivalent	COE LABORATORIES, INC.
K850036	COLTENE PRECISE	Feb 08, 1985	Substantially Equivalent	COLTENE, INC.
K844329	SURFLEX F	Dec 03, 1984	Substantially Equivalent	G-C INTL. CORP.
K842324	PERFOURM	Nov 09, 1984	Substantially Equivalent	CUTTER LABORATORIES, INC.
K843145	TWO COMPONENT RTV VINYL SILICONE MATER	Oct 18, 1984	Substantially Equivalent	CROWN DELTA CORP.
K841490	POLYSULFIDE CUSTOM TRAY MATERIAL	Jun 27, 1984	Substantially Equivalent	BUFFALO DENTAL MFG. CO., INC.
K830044	ODONTIC CENTRIC(BITE) REGIST. PASTE	Apr 06, 1983	Substantially Equivalent	WALLACE A. ERICKSON & CO.
K830083	SHUR GEL	Feb 07, 1983	Substantially Equivalent	COLUMBUS DENTAL MFG. CO.
K821221	DENTAL IMPRESSION MATERIAL	Jun 07, 1982	Substantially Equivalent	CROWN DELTA CORP.
K820489	ULTRAFINE TRAY ADHESIVE	Mar 19, 1982	Substantially Equivalent	BUFFALO DENTAL MFG. CO., INC.
K820216	ULTRA-WET	Feb 24, 1982	Substantially Equivalent	BUFFALO DENTAL MFG. CO., INC.
K820183	SYBRON/KERR MIRROR 3	Feb 24, 1982	Substantially Equivalent	SYBRON CORP.
K820061	REVERSIBLE HYDROCOLLOID IMPRESSION MAT	Feb 22, 1982	Substantially Equivalent	BELPORT CO., INC.
K812679	G-C FIT-CHECKER IMPRESSION MATERIAL	Oct 06, 1981	Substantially Equivalent	G-C INTL. CORP.
K812406	EXAFLEX IMPRESSION MATERIAL	Oct 06, 1981	Substantially Equivalent	G-C INTL. CORP.
K811867	SR-ALGICAP	Oct 02, 1981	Substantially Equivalent	J. ADERER, INC.
K811767	COLTENE PRESIDENT IMPRESSION MATERIALS	Jul 15, 1981	Substantially Equivalent	COLTENE, INC.
K811667	COLTENE PRESSURE SPOT INDICATOR	Jul 15, 1981	Substantially Equivalent	COLTENE, INC.
K811666	COLTENE COLTEX/COLTOFLAX	Jul 15, 1981	Substantially Equivalent	COLTENE, INC.
K811020	REVERSIBLE HYDROCOLLOID IMPRESSION	May 05, 1981	Substantially Equivalent	KOTTLER LABORATORIES
K810839	SPOTAR	Apr 29, 1981	Substantially Equivalent	MOYCO INDUSTRIES, INC.
K810825	POLYVINYL SILICONE IMPRESSION MATERIAL	Apr 14, 1981	Substantially Equivalent	DENTAL-MATERIAL GESELLSCHAFT
K810523	SR-IVOSEAL	Apr 14, 1981	Substantially Equivalent	J. ADERER, INC.
K802990	ALGINATE/SILICONE CROWN & BRIDGE MATER	Feb 02, 1981	Substantially Equivalent	BUFFALO DENTAL MFG. CO., INC.
K802882	HYDROCOLLOID COMPATIBLE CREAM ALGINATE	Jan 28, 1981	Substantially Equivalent	BUFFALO DENTAL MFG. CO., INC.
K802362	ALGINATE IMPRESSION MATERIAL	Oct 10, 1980	Substantially Equivalent	DENTSPLY INTL.
K802189	DENTLOID	Sep 26, 1980	Substantially Equivalent	U.S. SHIZAI CORP.
K801587	ASH BLUEPRINT ALGINATE IMPRESSION MATER.	Jul 21, 1980	Substantially Equivalent	DENTSPLY INTL.
K801380	CROWN DELTA SILICONE IMPRESSION MATERIAL	Jul 08, 1980	Substantially Equivalent	CROWN DELTA CORP.
K800393	POLY SULFIDE IMPRESSION PASTE W/CATALYST	Apr 10, 1980	Substantially Equivalent	AMERICAN DENTAL RESEARCH
K800548	SUPERSIL	Mar 18, 1980	Substantially Equivalent	HARRY J. BOSWORTH CO.
K800485	VINYL POLYSILOXANE IMPRESSION MATERIAL	Mar 18, 1980	Substantially Equivalent	3M COMPANY
K800031	PERMADYNE POLYETHER RUBBER IMPRESSION	Feb 05, 1980	Substantially Equivalent	ESPE DENTAL PRODUCTS
K792363	SILAGUM	Jan 09, 1980	Substantially Equivalent	PARKELL, INC.
K790595	DENTAL ALGINATE IMPRESSION MATERIAL	Jun 15, 1979	Substantially Equivalent	WALLACE A. ERICKSON & CO.
K790592	IMPRESSION MATERIAL, RUBBER	Jun 15, 1979	Substantially Equivalent	WALLACE A. ERICKSON & CO.
K782139	ZYLOX	Feb 21, 1979	Substantially Equivalent	PREMIER DENTAL PRODUCTS CO.
K781689	REFLECT IMPRESSION MATERIAL	Nov 15, 1978	Substantially Equivalent	KERR CORPORATION (DANBURY)
K781151	REPROSIL	Aug 31, 1978	Substantially Equivalent	DENTSPLY INTL.
K781083	DENTAL SILICONE IMPRESSION MATERIAL	Aug 31, 1978	Substantially Equivalent	CROWN DELTA CORP.
K780778	RTV SILICONE HAND KNEADABLE PUTTY	May 31, 1978	Substantially Equivalent	CROWN DELTA CORP.
K780164	RTV DENTAL SILICONE	Mar 15, 1978	Substantially Equivalent	TYDONT, INC.
K771938	ALGINATE IMPRESSION MATERIAL	Nov 02, 1977	Substantially Equivalent	THE S. S. WHITE CO.
K771853	PERMAGUM ADHESIVE	Oct 13, 1977	Substantially Equivalent	ESPE GMBH (US)
K771627	PERMAGUM	Sep 02, 1977	Substantially Equivalent	ESPE GMBH (US)
K771248	SILICONE IMPRESSION MATEOIAL	Jul 15, 1977	Substantially Equivalent	INTERSTATE DENTAL CO., INC.
K760981	ALGINATE IMPRESSION MATERIAL	Nov 15, 1976	Substantially Equivalent	ADP INTL., INC.
K760753	CUTTER JEL-ALGINATE IMPRESSION MAT.	Oct 20, 1976	Substantially Equivalent	CUTTER LABORATORIES, INC.
K760755	CUTTER SIL-SILICONE IMPRESSION MAT	Oct 15, 1976	Substantially Equivalent	CUTTER LABORATORIES, INC.
K760752	CUTTER FLEX-SILICONE IMPRESSION MAT.	Oct 15, 1976	Substantially Equivalent	CUTTER LABORATORIES, INC.
K760240	IMPRESSION MATERIAL, TRIFLEX SILICONE	Jul 26, 1976	Substantially Equivalent	ORATEC DENTAL PRODUCTS
K760238	IMPRESSION MATERIAL, TRIFLEX SILICONE	Jul 26, 1976	Substantially Equivalent	ORATEC DENTAL PRODUCTS
K760231	IMPRESSION MATERIAL, DENTAL SILICON RTV	Jul 21, 1976	Substantially Equivalent	CROWN DELTA CORP.
K760226	PASTE, ACCOE IMPRESSION	Jul 21, 1976	Substantially Equivalent	COE LABORATORIES, INC.
K760225	PUTTY, ACCOE	Jul 21, 1976	Substantially Equivalent	COE LABORATORIES, INC.

FEI Numbers

This FDA classification entry is associated with 147 FEI numbers. Click on an entry to view related FDA registrations.

1000132261: 32 registrations

1000137528: 104 registrations

1000231788: 50 registrations

1000254146: 7 registrations

1000293792: 20 registrations

1000486347: 11 registrations

1000531402: 15 registrations

1000554802: 31 registrations

1032227: 93 registrations

1281412: 38 registrations

1316092: 17 registrations

1410097: 126 registrations

1413475: 53 registrations

1450653: 53 registrations

1712259: 18 registrations

1718476: 36 registrations

1718912: 102 registrations

1721647: 24 registrations

2014676: 28 registrations

2018957: 98 registrations

2020493: 56 registrations

2023950: 67 registrations

2024312: 150 registrations

2024949: 20 registrations

2081055: 12 registrations

2126683: 48 registrations

2183301: 191 registrations

2244812: 19 registrations

2411797: 47 registrations

2431069: 13 registrations

2515379: 99 registrations

2523320: 75 registrations

2921595: 65 registrations

3000368601: 106 registrations

3000719964: 98 registrations

3001236129: 9 registrations

3001746544: 72 registrations

3002649941: 3 registrations

3002718942: 129 registrations

3002729120: 30 registrations

3002806620: 35 registrations

3002806930: 78 registrations

3002807050: 47 registrations

3002807052: 50 registrations

3002807166: 35 registrations

3002808289: 76 registrations

3002809532: 60 registrations

3003103749: 7 registrations

3003136707: 3 registrations

3003215343: 44 registrations

3003381355: 18 registrations

3003449480: 25 registrations

3003618527: 13 registrations

3003667632: 34 registrations

3003719498: 59 registrations

3003762341: 29 registrations

3003775534: 7 registrations

3003941201: 3 registrations

3004150030: 41 registrations

3004158247: 20 registrations

3004443427: 2 registrations

3004536970: 4 registrations

3004605596: 3 registrations

3004793856: 11 registrations

3004966444: 86 registrations

3005172141: 5 registrations

3005174370: 52 registrations

3005176727: 41 registrations

3005554774: 49 registrations

3005558160: 44 registrations

3005628474: 14 registrations

3005665377: 39 registrations

3005907356: 25 registrations

3006066614: 519 registrations

3006113314: 28 registrations

3006191485: 7 registrations

3006223010: 26 registrations

3006316962: 18 registrations

3006349398: 19 registrations

3006694515: 34 registrations

3007028587: 9 registrations

3007054491: 26 registrations

3007120510: 12 registrations

3007353764: 10 registrations

3007577370: 21 registrations

3007743883: 21 registrations

3007746785: 5 registrations

3008320092: 18 registrations

3008512935: 21 registrations

3008582406: 20 registrations

3008648418: 21 registrations

3008792854: 10 registrations

3008822460: 45 registrations

3008875470: 111 registrations

3008898734: 22 registrations

3008912871: 85 registrations

3008922120: 6 registrations

3008957253: 2 registrations

3008966075: 9 registrations

3009432160: 10 registrations

3009496224: 106 registrations

3010131268: 18 registrations

3010407924: 8 registrations

3010419931: 59 registrations

3010605677: 176 registrations

3010664129: 21 registrations

3010862763: 91 registrations

3011187729: 4 registrations

3011203516: 14 registrations

3011500388: 11 registrations

3011649314: 85 registrations

3011689956: 141 registrations

3012041047: 19 registrations

3012173918: 2 registrations

3012187973: 201 registrations

3012312751: 16 registrations

3012354669: 33 registrations

3012421607: 606 registrations

3012477813: 56 registrations

3012494290: 762 registrations

3012502601: 33 registrations

3012636179: 178 registrations

3013012934: 2 registrations

3013020540: 2 registrations

3013755719: 75 registrations

3014615644: 28 registrations

3014683120: 127 registrations

3015143007: 7 registrations

3015332784: 7 registrations

3015527834: 5 registrations

3016447764: 19 registrations

3017575849: 3 registrations

3017618961: 11 registrations

3018507299: 33 registrations

3022516928: 21 registrations

3023401336: 5 registrations

3025307990: 17 registrations

3026297922: 481 registrations

3027494823: 4 registrations

3030159375: 3 registrations

3031886796: 82 registrations

3032193293: 11 registrations

3032312561: 12 registrations

3032435508: 1 registration

3034534213: 15 registrations

4321: 17 registrations

4565: 9 registrations