Product Code: EMA FDA class 2 21 CFR 872.3275

Cement, Dental

Dental

Dental Cement is a luting, base, or restorative material used to bond indirect restorations such as crowns and bridges to prepared teeth, provide a protective base layer within deep cavity preparations, or serve as a definitive restorative material in certain clinical situations. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is EMA, regulated under 21 CFR 872.3275 in the Dental (DE) specialty. This device is eligible for third-party review.

View on FDA

510(k)s

496

FEI Numbers

142

Registration Numbers

142

Unique Applicants

191

Years Active

Basic Information

Product Code: EMA
Device Class: FDA class 2
Regulation Number: 872.3275
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 496 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251470	ResiCem EX	Jul 11, 2025	Substantially Equivalent	Shofu Dental Corporation
K250156	Choice 2 DC	Jul 11, 2025	Substantially Equivalent	Bisco, Inc
K250566	EsCem RMGI	Jun 20, 2025	Substantially Equivalent	Spident Co., Ltd.
K242366	OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment	Jan 10, 2025	Substantially Equivalent	Overfibers S.r.l.
K240714	Insure® Universal; Insure® Universal Automix	Jul 24, 2024	Substantially Equivalent	Cosmedent Inc.
K241204	TopCEM-Veneer Light Cure Veneer Cement	Jun 28, 2024	Substantially Equivalent	Rizhao HuGe Biomaterials Company, Ltd.
K240888	Calibra Abutment Resin Cement	Apr 02, 2024	Substantially Equivalent	Dentsply Sirona
K233161	BeautiLink SA	Sep 28, 2023	Substantially Equivalent	Shofu Dental Corporation
K231552	Dia-Cem	Jul 28, 2023	Substantially Equivalent	Diadent Group International
K214076	EsCem	Dec 19, 2022	Substantially Equivalent	SPIDENT CO., LTD.
K222253	GlasIonomer FX ULTRA	Sep 22, 2022	Substantially Equivalent	Shofu Dental Corporation
K214118	Riva Cem Automix	Aug 30, 2022	Substantially Equivalent	SDI Limited
K220640	Bifix Hybrid Abutment Cement	Aug 23, 2022	Substantially Equivalent	VOCO GmbH
K213609	NOVA RESIN dual cure, self adhesive resin cement	Aug 09, 2022	Substantially Equivalent	Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.
K213201	DeltaFil, DeltaFil Conditioner	Jun 01, 2022	Substantially Equivalent	DMG Chemisch-Pharmazeutische Fabrik GmbH
K210259	Parkell Self-Adhesive Cement	Jan 20, 2022	Substantially Equivalent	Parkell, Inc
K210473	Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)	Nov 02, 2021	Substantially Equivalent	Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.
K211237	UltraTemp Rez II	Jul 13, 2021	Substantially Equivalent	Ultradent Products, Inc.
K210504	PANAVIA Veneer LC	Jun 11, 2021	Substantially Equivalent	Kuraray Noritake Dental Inc.
K200555	Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)	May 13, 2021	Substantially Equivalent	Prevest Denpro Limited
K200798	G-CEM ONE	Nov 24, 2020	Substantially Equivalent	GC America Inc.
K201937	Ceramir Restore QuikCap	Nov 13, 2020	Substantially Equivalent	Doxa Dental AB
K201790	Dual Cure Resin Cement	Sep 29, 2020	Substantially Equivalent	Rizhao HuGe Biomaterials Company, Ltd.
K201856	Provicol QM Aesthetic	Aug 26, 2020	Substantially Equivalent	VOCO GmbH
K193260	U-Cem Premium & MAZIC Cem	Aug 21, 2020	Substantially Equivalent	Vericom Co., Ltd.
K193484	GC Fuji Triage EP	Jul 02, 2020	Substantially Equivalent	GC America Inc.
K192007	TheraBase, TheraBase Ca	Mar 17, 2020	Substantially Equivalent	Bisco, Inc.
K192530	Surefil one Self-adhesive Composite Hybrid	Jan 23, 2020	Substantially Equivalent	Dentsply Sirona
K191527	Visalys CemCore, Visalys Cem Core Try In Paste	Nov 08, 2019	Substantially Equivalent	Kettenbach GmbH & Co. KG
K192992	Suglue 3	Nov 05, 2019	Substantially Equivalent	3M Deutschland GMBH
K183465	Allcem, Allcem Core	Nov 02, 2019	Substantially Equivalent	Dentscare LTDA
K191548	Nexus Universal Self-Cure	Oct 11, 2019	Substantially Equivalent	Kerr Corporation
K182854	GC FujiCEM 2 (Improved)	Jul 11, 2019	Substantially Equivalent	GC America Inc.
K191122	3M RelyX Pediatric Resin Modified Glass Ionomer Cement	May 29, 2019	Substantially Equivalent	3M ESPE Dental Products
K183537	PANAVIA SA Cement Universal	Apr 25, 2019	Substantially Equivalent	Kuraray Noritake Dental Inc.
K171449	Metacem	May 15, 2018	Substantially Equivalent	Meta Biomed Co., Ltd
K180386	Meron Plus QM	May 08, 2018	Substantially Equivalent	Voco GmbH
K172382	GC Fuji Direct	Apr 02, 2018	Substantially Equivalent	GC America Inc.
K162960	TotalC-Ram	Mar 14, 2017	Substantially Equivalent	ITENA CLINICAL
K160345	Glass Ionomer Cement	Mar 03, 2017	Substantially Equivalent	SHANDONG HUGE DENTAL MATERIAL CORPORATION
K170330	3M Protemp Cement Temporary Dental Cement	Feb 06, 2017	Substantially Equivalent	3M Company
K160800	DuoCem	Nov 16, 2016	Substantially Equivalent	COLTENE/WHALEDENT AG
K161851	Glass Ionomer Cement (Luting)	Oct 31, 2016	Substantially Equivalent	SHANDONG HUGE DENTAL MATERIAL CORPORATION
K160443	TempoCem Clear	Sep 30, 2016	Substantially Equivalent	DMG USA, INC.
K160774	IonoStar Plus	Aug 03, 2016	Substantially Equivalent	VOCO GMBH
K161256	TheraCem	Jul 29, 2016	Substantially Equivalent	BISCO, INC.
K153231	G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer	Jul 06, 2016	Substantially Equivalent	GC AMERICA, INC.
K142130	ORAL BOND	Jun 06, 2016	Substantially Equivalent	STEINER LABORATORIES
K153174	Ketac Universal Aplicap	Apr 13, 2016	Substantially Equivalent	3M DEUTSCHLAND GMBH
K152652	PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement	Apr 05, 2016	Substantially Equivalent	GAIA DENTAL PRODUCTS, INC.
K152691	EDS Universal Cement	Feb 25, 2016	Substantially Equivalent	ESSENTIAL DENTAL SYSTEMS, INC
K151526	Zone, ZoneFree, Zone A1	Sep 10, 2015	Substantially Equivalent	SYBRON DENTAL SPECIALTIES
K150704	PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer	Aug 21, 2015	Substantially Equivalent	KURARAY NORITAKE DENTAL, INC.
K151332	Nexus Universal, Nexus Universal Chroma	Aug 17, 2015	Substantially Equivalent	SYBRON DENTAL SPECIALTIES
K150601	Zeramic Adhesive Resin Cement	Jul 22, 2015	Substantially Equivalent	Premier Dental Company Products
K150727	ESTECEM	Jun 17, 2015	Substantially Equivalent	TOKUYAMA DENTAL CORPORATION
K142446	Fixtemp Cement	Jun 04, 2015	Substantially Equivalent	EXACTA DENTAL DIRECT, INC
K143212	Bifix Temp	May 01, 2015	Substantially Equivalent	VOCO GMBH
K142623	PANAVIA SA Cement Plus Handmix	Feb 26, 2015	Substantially Equivalent	KURARAY NORITAKE DENTAL, INC.
K142625	PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS)	Jan 27, 2015	Substantially Equivalent	KURARAY NORITAKE DENTAL INC.
K141503	DENALI 501CEMENT	Nov 10, 2014	Substantially Equivalent	DENALI CORPORATION
K140993	IONOSTAR MOLAR	Oct 20, 2014	Substantially Equivalent	VOCO GMBH
K134021	ESTEMP IMPLANT, ESTEMP CLEAR	Jun 10, 2014	Substantially Equivalent	SPIDENT CO., LTD.
K132393	CERCOM II CEMENT	Mar 14, 2014	Substantially Equivalent	DENALI CORPORATION
K132255	ULTRACEM	Oct 24, 2013	Substantially Equivalent	ULTRADENT PRODUCTS INC. / ORATECH LLC
K130436	MULTILINK HYBRID ABUTMENT CEMENT	Aug 20, 2013	Substantially Equivalent	IVOCLAR VIVADENT AG
K130421	MERON APPLICATION CAPSULES	Aug 14, 2013	Substantially Equivalent	VOCO GMBH
K122551	PROVITEMP	Jun 14, 2013	Substantially Equivalent	ITENA CLINICAL
K122974	TRYOUT-VPS HOLDING PASTE	May 17, 2013	Substantially Equivalent	CROWN DELTA CORP.
K122549	DENTO TEMP	Apr 26, 2013	Substantially Equivalent	ITENA CLINICAL
K121804	PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM	Apr 19, 2013	Substantially Equivalent	ITENA CLINICAL
K130223	RMGI FILL	Mar 29, 2013	Substantially Equivalent	PULPDENT CORPORATION
K123824	VITRO FIL LC	Feb 21, 2013	Substantially Equivalent	DFL INDUSTRIA E COMERCIO S.A.
K123595	NEXUS RMGI	Feb 19, 2013	Substantially Equivalent	KERR CORPORATION
K123826	VITRO MOLAR	Feb 14, 2013	Substantially Equivalent	DFL INDUSTRIA E COMERCIO S.A.
K121621	SOLOCEM	Jan 08, 2013	Substantially Equivalent	COLTENE/WHALEDENT AG
K123273	HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)	Dec 07, 2012	Substantially Equivalent	TEMREX CORP.
K123265	RMGI LOW VISCOSITY	Dec 07, 2012	Substantially Equivalent	PULPDENT CORPORATION
K120283	DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT	Jul 31, 2012	Substantially Equivalent	NOVOCOL, INC.
K120243	GAM-200	Jun 27, 2012	Substantially Equivalent	GC AMERICA INC.
K120159	BEAUTICEM SA	Jun 18, 2012	Substantially Equivalent	SHOFU DENTAL CORPORATION
K120432	TELIO CS CEM IMPLANT	Jun 08, 2012	Substantially Equivalent	IVOCLAR VIVADENT AG
K120379	PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S	Mar 30, 2012	Substantially Equivalent	KURARAY MEDICAL INC.
K120378	PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S	Mar 30, 2012	Substantially Equivalent	KURARAY MEDICAL INC.
K112307	RESIGLASS PASTE	Mar 28, 2012	Substantially Equivalent	SHOFU DENTAL CORPORATION
K112574	PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT	Jan 23, 2012	Substantially Equivalent	PRIME DENTAL MANUFACTURING, INC.
K113040	CERAMIR CROWN & BRIDGE	Dec 28, 2011	Substantially Equivalent	DOXA DENTAL AB
K111855	HY-BOND RESIGLASS	Nov 17, 2011	Substantially Equivalent	SHOFU DENTAL CORP.
K111836	PERMASHADE VENEER CEMENT	Sep 16, 2011	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K111685	IP TEMP CEMENT	Sep 02, 2011	Substantially Equivalent	SHOFU DENTAL CORPORATION
K111017	CLEARTEMP	Jun 06, 2011	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K110508	SUGLUE-10	Jun 03, 2011	Substantially Equivalent	3M ESPE AG
K111185	RELYX LUTING PLUS AUTOMIX	May 05, 2011	Substantially Equivalent	3M ESPE DENTAL PRODUCTS
K103585	BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP	Mar 04, 2011	Substantially Equivalent	HARRY J. BOSWORTH CO.
K102612	VOCO IONOFIL MOLAR AC QUICK	Nov 19, 2010	Substantially Equivalent	VOCO GMBH
K101504	TI-CORE FLOW	Oct 29, 2010	Substantially Equivalent	ESSENTIAL DENTAL SYSTEMS, INC.
K101787	DUOLINK II	Oct 08, 2010	Substantially Equivalent	BISCO, INC.
K101869	PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)	Sep 29, 2010	Substantially Equivalent	SILMET LTD.
K101420	GC FUJI TEMP	Sep 17, 2010	Substantially Equivalent	GC AMERICA, INC.
K101493	ADVANCED GLASS IONOMER (K-130) RESTORATIVE	Aug 19, 2010	Substantially Equivalent	DENTSPLY INTERNATIONAL, INC.
K100247	DETAX IMPLANTLINK SEMI	Jul 23, 2010	Substantially Equivalent	DETAX GMBH & CO. KG
K100908	UNICEM HM	Jun 22, 2010	Substantially Equivalent	3M ESPE AG DENTAL PRODUCTS
K101044	RETRIEVE IMPLANT CEMENT	Jun 10, 2010	Substantially Equivalent	PARKELL, INC.
K100756	MALTA	Jun 02, 2010	Substantially Equivalent	3M ESPE AG DENTAL PRODUCTS
K094007	UNICEM	Apr 08, 2010	Substantially Equivalent	3M ESPE AG DENTAL PRODUCTS
K100510	CERAMIR CROWN & BRIDGE	Mar 25, 2010	Substantially Equivalent	DOXA AB
K100290	ESTEMP NE	Feb 17, 2010	Substantially Equivalent	SPIDENT CO., LTD.
K093338	SELF ADHESIVE COMPOSITE LUTING CEMENT	Feb 12, 2010	Substantially Equivalent	DMG USA, INC.
K091735	DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT	Sep 25, 2009	Substantially Equivalent	S & C POLYMER GMBH
K090817	IONOLUX	Jul 23, 2009	Substantially Equivalent	VOCO GMBH
K091106	EQUIA	Jun 17, 2009	Substantially Equivalent	GC AMERICA, INC.
K091019	SPEEDCEM	Jun 04, 2009	Substantially Equivalent	IVOCLAR VIVADENT, INC.
K083766	PHOGLASS CEM	Mar 02, 2009	Substantially Equivalent	S & C POLYMER GMBH
K083516	PERIOGENIX	Feb 20, 2009	Substantially Equivalent	OROSCIENCE, INC.
K083438	BIFIX SE	Feb 13, 2009	Substantially Equivalent	VOCO GMBH
K083304	TEMPOSIL 2	Feb 06, 2009	Substantially Equivalent	COLTENE/WHALEDENT AG
K083398	CERCOM CEMENT	Jan 26, 2009	Substantially Equivalent	DENALI R&D CORPORATION
K082115	PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT	Jan 15, 2009	Substantially Equivalent	S & C POLYMER GMBH
K082449	BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012	Sep 25, 2008	Substantially Equivalent	BISCO, INC.
K081913	METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER	Sep 05, 2008	Substantially Equivalent	META BIOMED CO., LTD.
K081702	CARBOXYLATE CEM, PHOSPHATE CEM	Sep 05, 2008	Substantially Equivalent	S & C POLYMER GMBH
K081887	LUTE-IT II VENEER CEMENT, MODEL NO6	Aug 29, 2008	Substantially Equivalent	PENTRON CLINICAL TECHNOLOGIES
K081405	XERACEM	Aug 21, 2008	Substantially Equivalent	DOXA DENTAL AB
K081583	CLEARFIL SA CEMENT	Jul 28, 2008	Substantially Equivalent	KURARAY MEDICAL INC.
K080517	RESICEM	Jun 11, 2008	Substantially Equivalent	SHOFU DENTAL CORP.
K080768	ULTRATEMP FIRM, FAST AND REGULAR SET	Apr 11, 2008	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K073698	SECURE	Mar 19, 2008	Substantially Equivalent	PARKELL, INC.
K073283	GC GAM-100	Feb 20, 2008	Substantially Equivalent	GC AMERICA, INC.
K073173	SELF-ADHESIVE RESIN CEMENT	Jan 23, 2008	Substantially Equivalent	DENTSPLY INTERNTIONAL
K073395	GILB-2, GLASS IONOMER PROTECTIVE COATING	Jan 17, 2008	Substantially Equivalent	3M ESPE DENTAL PRODUCTS
K073101	AURAVENEER CEMENT	Jan 17, 2008	Substantially Equivalent	DENALI CORPORATION
K073043	SET PP	Dec 14, 2007	Substantially Equivalent	SDI LTD.
K072604	DUO TEMP	Nov 16, 2007	Substantially Equivalent	COLTENE/WHALEDENT AG
K071484	PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040	Oct 10, 2007	Substantially Equivalent	GLUSTITCH, INC.
K070840	GVC-100	May 15, 2007	Substantially Equivalent	GC AMERICA, INC.
K070319	GC FUJI IX GP EXTRA	Feb 26, 2007	Substantially Equivalent	GC AMERICA, INC.
K063554	MERON PLUS	Jan 12, 2007	Substantially Equivalent	VOCO GMBH
K062355	ENA CEM	Dec 27, 2006	Substantially Equivalent	MICERIUM S.P.A.
K062065	RIVA LUTING PLUS	Nov 15, 2006	Substantially Equivalent	SOUTHERN DENTAL INDUSTRIES, INC.
K062064	RIVA BOND LC	Nov 09, 2006	Substantially Equivalent	SOUTHERN DENTAL INDUSTRIES, INC.
K062292	UNICEM	Oct 25, 2006	Substantially Equivalent	3M ESPE DENTAL PRODUCTS
K062519	NEXUS 3	Oct 19, 2006	Substantially Equivalent	KERR CORPORATION
K062410	CLEARFIL ESTHETIC CEMENT & DC BOND	Sep 26, 2006	Substantially Equivalent	KURARAY MEDICAL INC.
K061781	MULTILINK SPRINT	Sep 05, 2006	Substantially Equivalent	IVOCLAR VIVADENT, INC.
K061535	GC XLC-100 CAPSULE	Jul 14, 2006	Substantially Equivalent	GC AMERICA, INC.
K060701	BISCEM TRANSLUCENT, BISCEM OPAQUE	May 15, 2006	Substantially Equivalent	BISCO, INC.
K060698	CEMENT-IT ALL PURPOSE, MODEL N97	May 10, 2006	Substantially Equivalent	PENTRON CLINICAL TECHNOLOGIES
K060894	BIFIX QM	May 02, 2006	Substantially Equivalent	VOCO GMBH
K060334	GI DENTSTAT	Feb 23, 2006	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K053565	TEMPBOND CLEAR WITH TRICLOSAN	Feb 03, 2006	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K053040	PARACEM UNIVERSAL DC	Nov 09, 2005	Substantially Equivalent	COLTENE/WHALEDENT AG
K052235	LCR	Sep 27, 2005	Substantially Equivalent	3M COMPANY
K051952	EUGENONE	Sep 07, 2005	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K051866	PREMIER TEMPORARY CEMENT	Sep 06, 2005	Substantially Equivalent	PREMIER DENTAL PRODUCTS CO.
K051427	GC FUJI FIL LC	Aug 22, 2005	Substantially Equivalent	GC AMERICA, INC.
K051008	SET	Jun 15, 2005	Substantially Equivalent	SOUTHERN DENTAL INDUSTRIES, LTD.
K050870	RIVA LIGHT CURE	Jun 03, 2005	Substantially Equivalent	SOUTHERN DENTAL INDUSTRIES, INC.
K050658	RESO-PAC PERIODONTAL DRESSING	May 27, 2005	Substantially Equivalent	HAGER WORLDWIDE, INC.
K050426	TEMPOSIL, MODEL 6720	Mar 18, 2005	Substantially Equivalent	COLTENE/WHALEDENT AG
K042846	SYSTEMP.LINK	Dec 20, 2004	Substantially Equivalent	IVOCLAR VIVADENT, INC.
K042847	SYSTEMP.CEM	Dec 17, 2004	Substantially Equivalent	IVOCLAR VIVADENT, INC.
K042452	RIVA SILVER	Dec 07, 2004	Substantially Equivalent	SOUTHERN DENTAL INDUSTRIES, INC.
K042669	IONOFIL PLUS AC	Oct 20, 2004	Substantially Equivalent	VOCO GMBH
K041272	DYRACT CEM PLUS CEMENT	Oct 18, 2004	Substantially Equivalent	DENTSPLY INTL.
K042215	RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT	Sep 21, 2004	Substantially Equivalent	PREMIER DENTAL PRODUCTS CO.
K040343	TEMP F	Aug 03, 2004	Substantially Equivalent	NOVOCOL, INC.
K041474	MAXCEM	Jul 21, 2004	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K040906	CALIBRA CEMENT	Jun 16, 2004	Substantially Equivalent	DENTSPLY INTL.
K040895	INTEGRITY TEMPORARY CEMENT	May 21, 2004	Substantially Equivalent	DENTSPLY INTL.
K040393	RIVA LUTING	Apr 30, 2004	Substantially Equivalent	SOUTHERN DENTAL INDUSTRIES, INC.
K040236	PULPDENT VLC RESIN CEMENT	Apr 20, 2004	Substantially Equivalent	PULPDENT CORPORATION
K033309	PREMIER IMPLANT CEMENT, MODEL 3001450	Jan 26, 2004	Substantially Equivalent	PREMIER DENTAL PRODUCTS CO.
K031494	DOC'S BEST WHITE COPPER CEMENT	Nov 12, 2003	Substantially Equivalent	COOLEY & COOLEY, LTD.
K032455	PANAVIA F 2.0	Nov 07, 2003	Substantially Equivalent	KURARAY MEDICAL INC.
K032470	MULTILINK	Nov 05, 2003	Substantially Equivalent	IVOCLAR VIVADENT, INC.
K032597	BISCEM GI	Nov 04, 2003	Substantially Equivalent	BISCO, INC.
K033068	IONOFIL COLOR AC	Oct 31, 2003	Substantially Equivalent	VOCO GMBH
K032175	DESENS-IONOMER	Oct 09, 2003	Substantially Equivalent	MILTON HODOSH, M.D.
K031752	COLTOSOL F	Aug 05, 2003	Substantially Equivalent	COLTENE/WHALEDENT INC.
K031467	GLASIONOMER FX-II	Jul 17, 2003	Substantially Equivalent	SHOFU DENTAL CORP.
K031212	TEMPORARY RESIN CEMENT	Jul 11, 2003	Substantially Equivalent	PARKELL, INC.
K030727	POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT	Jun 05, 2003	Substantially Equivalent	HEALEX PRODUCTS, INC.
K030516	RIVA-SELF CURE	Apr 17, 2003	Substantially Equivalent	SOUTHERN DENTAL INDUSTRIES, INC.
K030168	AGC CEM	Mar 21, 2003	Substantially Equivalent	WIELAND DENTAL + TECHNIK GMBH & CO. KG
K024287	FIXOBRIDGE 3-CEMENT	Mar 21, 2003	Substantially Equivalent	ADVANCED HEALTHCARE LTD.
K023888	CIMOFLUOR	Mar 05, 2003	Substantially Equivalent	GLOBAL DENTAL PRODUCTS, INC.
K023981	AHL GENERIC GLASS IONOMER LUTING CEMENT	Jan 31, 2003	Substantially Equivalent	ADVANCED HEALTHCARE LTD.
K023649	VITIQUE SYSTEM	Jan 17, 2003	Substantially Equivalent	DMG USA, INC.
K023727	TEMPORARY CEMENT-DC010002	Jan 16, 2003	Substantially Equivalent	GC AMERICA, INC.
K022150	TRIONOMER	Aug 21, 2002	Substantially Equivalent	PENTRON CLINICAL TECHNOLOGIES
K022476	RELYX RMGIP	Aug 02, 2002	Substantially Equivalent	3M COMPANY
K021038	GC ELITE CEMENT 100	May 03, 2002	Substantially Equivalent	GC AMERICA, INC.
K020481	PULPDENT POST CEMENT	Apr 17, 2002	Substantially Equivalent	PULPDENT CORPORATION
K020376	AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE	Apr 09, 2002	Substantially Equivalent	ADVANCED HEALTHCARE LTD.
K020256	UNICEM	Mar 25, 2002	Substantially Equivalent	3M ESPE AG DENTAL PRODUCTS
K020117	GC FUJI LINING LC PASTE PAK	Feb 28, 2002	Substantially Equivalent	GC AMERICA, INC.
K013555	SCI-PHARM POST SECURE	Jan 23, 2002	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K013609	NEXUS 2 CLEAR	Jan 16, 2002	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K013446	GLUSITE, MODEL GLU002	Dec 20, 2001	Substantially Equivalent	GLUSTITCH, INC.
K013198	FUJI VII CAPSULE	Oct 29, 2001	Substantially Equivalent	GC AMERICA, INC.
K013008	NEXUS 2 MODIFIED	Oct 02, 2001	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K012735	CLEARFIL DC CEMENT	Sep 14, 2001	Substantially Equivalent	KURARAY MEDICAL INC.
K012441	PANAVIA F	Sep 06, 2001	Substantially Equivalent	KURARAY MEDICAL INC.
K012438	MODIFICATION TO PANAVIA 21	Sep 05, 2001	Substantially Equivalent	KURARAY MEDICAL INC.
K011854	TOKUYAMA M-BOND	Sep 04, 2001	Substantially Equivalent	TOKUYAMA AMERICA, INC.
K012316	PERMACEM / PERMACEM DUAL	Aug 23, 2001	Substantially Equivalent	DMG USA, INC.
K011685	BISTITE II DC	Jul 31, 2001	Substantially Equivalent	TOKUYAMA AMERICA, INC.
K010541	PREVISION CHEM	Jul 31, 2001	Substantially Equivalent	HERAEUS KULZER, INC.
K011520	RESTORE-X	Jul 23, 2001	Substantially Equivalent	FIRST SCIENTIFIC LIMITED
K011200	GILB, MODEL 8010	Jun 14, 2001	Substantially Equivalent	3M COMPANY
K011431	RESIN CEM	Jun 11, 2001	Substantially Equivalent	S & C POLYMER GMBH
K011159	ONE-STEP PLUS	Jun 08, 2001	Substantially Equivalent	BISCO, INC.
K011064	CLASSIC CEM	May 17, 2001	Substantially Equivalent	S & C POLYMER GMBH
K010240	POLYCARBOXYLATE (PCA) CEMENT	Mar 27, 2001	Substantially Equivalent	RITE-DENT MANUFACTURING CORP.
K003407	SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)	Jan 26, 2001	Substantially Equivalent	IVOCLAR NORTH AMERICA, INC.
K003921	DYRACT CEM LCI COMPOMER	Jan 24, 2001	Substantially Equivalent	DENTSPLY INTL.
K003427	ZINC PHOSPHATE CEMENT	Jan 24, 2001	Substantially Equivalent	RITE-DENT MANUFACTURING CORP.
K003791	CAVEX TEMPORARY CEMENT	Jan 23, 2001	Substantially Equivalent	CAVEX HOLLAND B.V.
K003658	TEMP-BOND NE 2	Jan 04, 2001	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K002843	SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010	Nov 15, 2000	Substantially Equivalent	SULTAN CHEMISTS, INC.
K002452	3M RELY X VENEER CEMENT TRY-IN PASTER	Sep 28, 2000	Substantially Equivalent	3M COMPANY
K002793	KETAC CEM U	Sep 26, 2000	Substantially Equivalent	ESPE DENTAL AG
K002461	HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT	Sep 26, 2000	Substantially Equivalent	SHOFU DENTAL CORP.
K002322	MODIFICATION TO PANAVIA F	Sep 18, 2000	Substantially Equivalent	KURARAY AMERICA, INC.
K001823	LINKMAX	Aug 16, 2000	Substantially Equivalent	GC AMERICA, INC.
K001730	GC FUJICEM	Jul 17, 2000	Substantially Equivalent	GC AMERICA, INC.
K000173	CEMENT IT! UNIVERSAL C&B	Feb 29, 2000	Substantially Equivalent	JENERIC/PENTRON, INC.
K994261	ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT	Feb 02, 2000	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K993556	LIQUIBAND DENTAL	Jan 03, 2000	Substantially Equivalent	MEDLOGIC GLOBAL CORP.
K993710	MODIFICATION OF PARAPOST CEMENT	Dec 21, 1999	Substantially Equivalent	COLTENE/WHALEDENT INC.
K993324	CARBOCEM ZINC POLYCARBOXYLATE CEMENT	Nov 09, 1999	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K991974	FUTURA GLASS IONOMER SILVER REINFORCED	Sep 17, 1999	Substantially Equivalent	AB ARDENT
K992160	NEXUS 2	Aug 18, 1999	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K991711	BISTITE II SC	Jul 07, 1999	Substantially Equivalent	TOKUYAMA AMERICA, INC.
K991172	IONOSIT BOND	May 17, 1999	Substantially Equivalent	DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
K990381	TOTALBOND	May 17, 1999	Substantially Equivalent	PARKELL, INC.
K990155	HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010	Feb 25, 1999	Substantially Equivalent	KAY SEE DENTAL MFG. CO.
K984505	MIRACLE MIX POWDER/LIQUID	Feb 04, 1999	Substantially Equivalent	GC AMERICA, INC.
K984340	STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281	Jan 08, 1999	Substantially Equivalent	STERNGOLD/IMPLAMED
K984248	PROCEM	Jan 08, 1999	Substantially Equivalent	ESPE DENTAL AG
K983752	ALUMINA-ZINC OXIDE POWDERS F AND R	Dec 10, 1998	Substantially Equivalent	HARRY J. BOSWORTH CO.
K983361	PANAVIA F	Nov 13, 1998	Substantially Equivalent	KURARAY AMERICA, INC.
K982773	QUICKSET LIQUID AND POWDER	Nov 03, 1998	Substantially Equivalent	SPECIALITES SEPTODONT
K983018	ZINC PHOSPHATE CEMENT	Oct 22, 1998	Substantially Equivalent	MEDENTAL INTL.
K982913	ZINFOS ZINC PHOSPHATE CEMENT	Oct 19, 1998	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K982895	STERNOMEGA COMPOMER CEMENT	Oct 09, 1998	Substantially Equivalent	STERNGOLD/IMPLAMED
K982590	TEMPBOND CLEAR-2	Oct 08, 1998	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K982779	MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1	Sep 30, 1998	Substantially Equivalent	MEDENTAL INTL.
K982400	STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT	Sep 23, 1998	Substantially Equivalent	STERI-OSS, INC.
K982665	JUMBO SILVER-REINFORCED GLASS IONOMER	Sep 08, 1998	Substantially Equivalent	CENTRIX, INC.
K982461	GLASIONOMER CEMENT CX PLUS	Aug 24, 1998	Substantially Equivalent	SHOFU DENTAL CORP.
K980990	POLYCARBOXYLATE CEMENT	Jul 31, 1998	Substantially Equivalent	MEDENTAL INTL.
K981618	LIQUID A	Jul 28, 1998	Substantially Equivalent	HARRY J. BOSWORTH CO.
K973636	MCS-MEDICATED CANAL SEALER	Jul 27, 1998	Substantially Equivalent	DR. HOWARD MARTIN, P.A.
K981965	FLOWABLE COMPOSITE	Jul 10, 1998	Substantially Equivalent	DENTSPLY INTL.
K981335	ARISTON PHC LINER	Jul 02, 1998	Substantially Equivalent	IVOCLAR NORTH AMERICA, INC.
K973201	PROVI CEMENT	Jun 05, 1998	Substantially Equivalent	S & C POLYMER GMBH
K981370	MIRACLE MIX CAPSULE	Jun 01, 1998	Substantially Equivalent	GC AMERICA, INC.
K980922	PROTEC CEM.	Apr 30, 1998	Substantially Equivalent	IVOCLAR NORTH AMERICA, INC.
K980568	JUMBO GLASS IONOMER CEMENT	Apr 30, 1998	Substantially Equivalent	CENTRIX, INC.
K980695	FUJI I	Apr 13, 1998	Substantially Equivalent	GC AMERICA, INC.
K980159	OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01	Apr 09, 1998	Substantially Equivalent	CLOSURE MEDICAL CORP.
K974097	PERIACRYL	Apr 09, 1998	Substantially Equivalent	BLACKLOCK MEDICAL PRODUCTS, INC.
K980682	FUJI II	Apr 03, 1998	Substantially Equivalent	GC AMERICA, INC.
K980232	CLEARFIL DC CEMENT	Feb 24, 1998	Substantially Equivalent	KURARAY COMPANY, LTD.
K974458	COMPOLUTE APLICAP	Feb 02, 1998	Substantially Equivalent	ESPE DENTAL-MEDIZIN GMBH & CO.KG.
K972935	SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL	Jan 29, 1998	Substantially Equivalent	S.S. WHITE MFG., LTD.
K974140	ADHESIVE HYBRID IONOMER CEMENT	Jan 05, 1998	Substantially Equivalent	DENTSPLY INTL.
K974014	PULPDENT DENTASTIC UNO	Dec 17, 1997	Substantially Equivalent	PULPDENT CORP.
K973961	3M DENT SYSTEM II PLUS	Dec 17, 1997	Substantially Equivalent	3M COMPANY
K973370	AQUAPLAST PALATAL STENT	Dec 02, 1997	Substantially Equivalent	WFR/AQUAPLAST CORP.
K973397	SYNTAC SPRINT	Nov 21, 1997	Substantially Equivalent	IVOCLAR NORTH AMERICA, INC.
K973262	KETAC-FIL APLICAP PLUS	Nov 17, 1997	Substantially Equivalent	ESPE GMBH & CO. KG.
K972965	STERI-OSS UNTIL IMPLANT CEMENT	Nov 07, 1997	Substantially Equivalent	STERI-OSS, INC.
K972844	TEMP BOND CLEAR	Oct 03, 1997	Substantially Equivalent	KERR DENTAL MATERIALS CENTER
K972445	PULPDENT OX-OUT	Oct 02, 1997	Substantially Equivalent	PULPDENT CORP.
K972485	CIMPAT N	Sep 08, 1997	Substantially Equivalent	ARENT, FOX, KINTNER, PLOTKIN & KAHN
K971642	DENTALIS KEZ ENDODONITC SEALER	Jul 24, 1997	Substantially Equivalent	NEO DENTAL CHEMICAL PRODUCTS CO., LTD.
K971927	HI DENSE TC	Jun 30, 1997	Substantially Equivalent	SHOFU DENTAL CORP.
K970775	TEMPO CEM (MULTIPLE)	Jun 03, 1997	Substantially Equivalent	FOREMOST DENTAL MFG., INC.
K970774	TEMPOCEM NE (MULTIPLE)	Jun 03, 1997	Substantially Equivalent	FOREMOST DENTAL MFG., INC.
K964808	SPETEMP	Feb 26, 1997	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K964773	DENTEMP ONE STEP	Feb 21, 1997	Substantially Equivalent	MAJESTIC DRUG CO., INC.
K964809	SPETEMP EF	Jan 02, 1997	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K963737	HYCEM APLICAP	Nov 15, 1996	Substantially Equivalent	ESPE GMBH & CO. KG.
K962733	CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920)	Oct 11, 1996	Substantially Equivalent	UNION BROACH, DIV. MOYCO INDUSTRIES, INC.
K962747	PULPDENT ENDODONTIC POST CEMENT KIT	Sep 30, 1996	Substantially Equivalent	PULPDENT CORP.
K963078	STERI-OSS TEMPORARY IMPLANT CEMENT	Sep 10, 1996	Substantially Equivalent	STERI-OSS, INC.
K962383	PULPDENT RESILUTE II	Sep 03, 1996	Substantially Equivalent	PULPDENT CORP.
K962065	3M VITREBOND LIGHT CURE GLASS IONOMER/BASE	Jul 18, 1996	Substantially Equivalent	3M COMPANY
K961448	FUJI IX GP	Jul 08, 1996	Substantially Equivalent	GC AMERICA, INC.
K962297	VIVAGLASS CEM	Jun 26, 1996	Substantially Equivalent	IVOCLAR NORTH AMERICA, INC.
K961910	VIVAGLASS FIL	Jun 26, 1996	Substantially Equivalent	IVOCLAR NORTH AMERICA, INC.
K961584	FUJI II LC (IMPROVED)	May 24, 1996	Substantially Equivalent	GC AMERICA, INC.
K960954	KETAC-MOLAR APLICAP	May 16, 1996	Substantially Equivalent	ESPE GMBH & CO. KG.
K960910	INDERMIL DENTAL	Mar 28, 1996	Substantially Equivalent	LOCTITE CORP.
K960464	C & B METABOND (MODIFICATION)	Feb 26, 1996	Substantially Equivalent	PARKELL, INC.
K955089	ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT	Dec 13, 1995	Substantially Equivalent	WALLACE A. ERICKSON & CO.
K955068	OPTIBOND 2A PRECOAT	Dec 11, 1995	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K955017	PULPDENT RESILUTE	Dec 01, 1995	Substantially Equivalent	PULPDENT CORP.
K954876	AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA	Nov 15, 1995	Substantially Equivalent	AMERICAN DENTAL PRODUCTS, INC.
K954762	NEXUS	Nov 02, 1995	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K954643	TRY-IN GEL	Oct 19, 1995	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K954177	ALPHA-BOND DENTIN BONDING SYSTEM	Sep 27, 1995	Substantially Equivalent	ALPHA-BOND, INC.
K953301	DENTASTIC ONE-STEP	Aug 25, 1995	Substantially Equivalent	PULPDENT CORP.
K953272	PULPDENT DENTASTIC II	Aug 25, 1995	Substantially Equivalent	PULPDENT CORP.
K952960	PULPDENT POST CEMENT	Jul 19, 1995	Substantially Equivalent	PULPDENT CORP.
K952121	3M RESIN CEMENT	Jun 22, 1995	Substantially Equivalent	3M MEDICAL PRODUCTS GROUP
K951270	PULPDENT GLASS IONOMER CEMENTS	May 31, 1995	Substantially Equivalent	PULPDENT CORP.
K951555	FUJI IX	May 23, 1995	Substantially Equivalent	GC AMERICA, INC.
K945451	HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE	Feb 27, 1995	Substantially Equivalent	SHOFU DENTAL CORP.
K950428	VIVAGLASS BASE	Feb 17, 1995	Substantially Equivalent	IVOCLAR NORTH AMERICA, INC.
K950060	PROVILINK	Feb 10, 1995	Substantially Equivalent	IVOCLAR NORTH AMERICA, INC.
K945366	PARAPOST CEMENT	Feb 02, 1995	Substantially Equivalent	COLTENE/WHALEDENT INC.
K946137	PULPDENT PERIODONTAL DRESSINGS	Jan 26, 1995	Substantially Equivalent	PULPDENT CORP.
K946100	FUJI DUET	Jan 20, 1995	Substantially Equivalent	GC AMERICA, INC.
K945244	PULP CANAL SEALER EWT	Dec 29, 1994	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K944480	SEALAPEX	Nov 03, 1994	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K942808	TYPE I GLASS IONOMER CEMENT	Nov 03, 1994	Substantially Equivalent	MION INTERNATIONAL CORP.
K926376	MION 525	Oct 21, 1994	Substantially Equivalent	MION INTERNATIONAL CORP.
K940914	NEW LUTING CEMENT MATERIAL (NLC)	Aug 29, 1994	Substantially Equivalent	DENTSPLY INTL.
K942665	ORTHOCENT: LIQUID AND POWDER	Jul 22, 1994	Substantially Equivalent	DENTAURAUM, INC.
K942596	ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND CEMENT	Jun 16, 1994	Substantially Equivalent	WALLACE A. ERICKSON & CO.
K941065	DEOX, OXYGEN BARRIER VISCOUS SOLUTION	Jun 16, 1994	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K935436	ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED	Jun 10, 1994	Substantially Equivalent	WALLACE A. ERICKSON & CO.
K940122	HY BOND, GLASIONOMER CX	May 02, 1994	Substantially Equivalent	SHOFU DENTAL CORP.
K940546	GRANITEC IONOMER RESIN CEMENT	Apr 29, 1994	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K940459	MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)	Apr 29, 1994	Substantially Equivalent	DENTSPLY INTL.
K933612	JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT)	Feb 24, 1994	Substantially Equivalent	JEDENTAL CO., INC.
K933030	PANAVIA 21	Feb 24, 1994	Substantially Equivalent	KURARAY CO.
K940030	BISCO COMPOSITE	Feb 04, 1994	Substantially Equivalent	BISCO, INC.
K934073	JEDENTAL GLASS IONOMER CEMENT AND LINER	Jan 26, 1994	Substantially Equivalent	JEDENTAL CO., INC.
K922250	FLEXI-FLOW CEMENT WITH TITANIUM	Jan 26, 1994	Substantially Equivalent	ESSENTIAL DENTAL SYSTEMS, INC.
K922249	FLEXI-FLOW CEMENT NATURAL	Jan 26, 1994	Substantially Equivalent	ESSENTIAL DENTAL SYSTEMS, INC.
K934405	PRECEDENT	Jan 21, 1994	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K935521	GC ELITE CEMENT	Jan 06, 1994	Substantially Equivalent	GC AMERICA, INC.
K933199	CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL	Jan 06, 1994	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K933139	3M VITREMER LUTING CEMENT	Jan 05, 1994	Substantially Equivalent	3M COMPANY
K934184	FASTFIL	Dec 13, 1993	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K933554	JEDENTAL ZINC CEMENT IMPROVED	Nov 01, 1993	Substantially Equivalent	JEDENTAL CO., INC.
K933543	ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)	Nov 01, 1993	Substantially Equivalent	JEDENTAL CO., INC.
K933459	RESIMENT WITH FLUORIDE	Oct 20, 1993	Substantially Equivalent	J.L. BLOSSER, INC.
K931229	VARIGLASS VLC GLASS IONOMER	Jul 08, 1993	Substantially Equivalent	DENTSPLY INTL.
K925207	GLASS IONOMER CEMENT	Jul 08, 1993	Substantially Equivalent	MILTON HODOSH, M.D.
K924132	E.Z. TEMEP, TEMPORARY FILLING MATERIAL	Jul 08, 1993	Substantially Equivalent	COSMEDENT, INC.
K925027	PHOTAC-FIL APLICAP	Jun 18, 1993	Substantially Equivalent	ESPE GMBH (US)
K930116	LCL 8	Jun 17, 1993	Substantially Equivalent	VOCO GMBH
K931084	TEMPIT	May 27, 1993	Substantially Equivalent	CENTRIX, INC.
K923473	MULTIPURPOSE RESIN CEMENT	Apr 12, 1993	Substantially Equivalent	DENTSPLY INTL.
K930455	CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER	Apr 08, 1993	Substantially Equivalent	VOCO GMBH
K926492	ARGION DENTAL CEMENT	Apr 08, 1993	Substantially Equivalent	VOCO GMBH
K926458	BIFIX DENTAL CEMENT	Mar 31, 1993	Substantially Equivalent	VOCO GMBH
K925713	VITA CEREC DUO CEMENT	Feb 17, 1993	Substantially Equivalent	VIDENT
K925032	3M VITREMER TRI-CURE GLASS IONOMER SYSTEM	Dec 23, 1992	Substantially Equivalent	3M COMPANY
K921173	TYPE 1 DENTAL CEMENT	Nov 04, 1992	Substantially Equivalent	CENTRIX, INC.
K923328	VENEER CEMENT	Sep 09, 1992	Substantially Equivalent	DENTSPLY INTL.
K922853	AQUA IONOFIL	Aug 10, 1992	Substantially Equivalent	VOCO GMBH
K922638	TEMPIT-E	Aug 10, 1992	Substantially Equivalent	CENTRIX, INC.
K922854	AQUA MERON	Aug 05, 1992	Substantially Equivalent	VOCO GMBH
K915666	AMALCODEN	Mar 25, 1992	Substantially Equivalent	MION INTERNATIONAL CORP.
K914318	GLASS IONOMER CEMENT	Mar 20, 1992	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K915619	IONOFIL/LONOFIL MOLAR	Feb 25, 1992	Substantially Equivalent	VOCO GMBH
K915618	PROVICOL	Feb 25, 1992	Substantially Equivalent	VOCO GMBH
K915467	CIMPAT S DENTAL CEMENT	Feb 03, 1992	Substantially Equivalent	SPECIALITES SEPTODONT
K914612	MERON DENTAL CEMENT	Feb 03, 1992	Substantially Equivalent	VOCO GMBH
K915005	PHOTAC-BOND APLICAP, MODIFICATION	Jan 14, 1992	Substantially Equivalent	ESPE GMBH (US)
K911061	ESPE KETAC-ENDO APLICAP	Jan 03, 1992	Substantially Equivalent	H.A. OPOTOW CONSULTING
K914324	CAVITY VARNISH PRODUCT	Dec 27, 1991	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K913519	SUMO GLASS IONOMER CEMENT	Nov 19, 1991	Substantially Equivalent	ORTHO SOURCE
K913884	FUJI II LC	Oct 30, 1991	Substantially Equivalent	G-C INTL. CORP.
K914073	F21(R) DENTAL CEMENT	Oct 21, 1991	Substantially Equivalent	VOCO GMBH
K913836	VLC GLASS IONOMER	Oct 17, 1991	Substantially Equivalent	DENTSPLY INTL.
K913572	AUTOPACK NON-EUGENOL PERIODONTAL DRESSING	Oct 09, 1991	Substantially Equivalent	SPECIALITES SEPTODONT
K912497	IONOBOND	Jul 30, 1991	Substantially Equivalent	VOCO GMBH
K911842	3M LUTING CEMENT, PASTE A AND B	Jun 17, 1991	Substantially Equivalent	3M COMPANY
K910719	SILICOATER MD	Apr 29, 1991	Substantially Equivalent	KULZER, INC.
K910424	TEETHMATE-F	Apr 03, 1991	Substantially Equivalent	KURARAY CO.
K904034	TEMPORARY DENTAL CEMENT	Dec 27, 1990	Substantially Equivalent	MEDICAL DEVICE INSPECTION CO., INC.
K904024	CEMPER	Nov 09, 1990	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K901524	CHEMFIL II CAPS	Sep 19, 1990	Substantially Equivalent	DENTSPLY INTL.
K902817	SURGI PAK NE AND COCOMENT EUGENAL FREE PASTE SYST	Aug 28, 1990	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K902392	COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL	Aug 28, 1990	Substantially Equivalent	COLTENE, INC.
K902078	ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY.	Aug 03, 1990	Substantially Equivalent	CRX MEDICAL, INC.
K902894	POST CEMENT (DENTAL COMPOSITE)	Aug 01, 1990	Substantially Equivalent	MEDICAL DEVICE INSPECTION CO., INC.
K902052	AHYDRON DENTAL CLEANING AGENT	Jul 13, 1990	Substantially Equivalent	IVOCLAR NORTH AMERICA, INC.
K902635	MODIFIED GRANITEC P2 & G2 DENTAL CEMENTS	Jul 10, 1990	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K901082	CYANODONT DENTAL CEMENT	Jul 09, 1990	Substantially Equivalent	SPECIALITES SEPTODONT
K896883	GC CERVICAL CEMENT	Jul 06, 1990	Substantially Equivalent	G-C INTL. CORP.
K902041	3M LUTING CEMENT - PASTE A AND PASTE B	Jun 27, 1990	Substantially Equivalent	3M COMPANY
K896340	BIOMER(R) F COMPOSITE LUTING CEMENT	May 15, 1990	Substantially Equivalent	DENTSPLY INTL.
K900342	UNITY DENTAL CEMENT	May 07, 1990	Substantially Equivalent	WHALEDENT INTL. DIV. IPCO
K895386	GLASION	Apr 16, 1990	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K900303	CONNECT	Apr 12, 1990	Substantially Equivalent	PARKELL
K895487	TEMPORARY DENTAL CEMENT	Apr 02, 1990	Substantially Equivalent	DENTSPLY INTL.
K897188	KETAC-CEM MAXICAP	Mar 27, 1990	Substantially Equivalent	ESPE GMBH (US)
K895988	POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL	Mar 07, 1990	Substantially Equivalent	MILTON HODOSH, M.D.
K896649	GRANITEC Z2, ZINC PHOSPHATE CEMENT	Feb 22, 1990	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K894953	GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS	Feb 06, 1990	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K896249	BANDTITE GLASS IONOMER CEMENT	Jan 26, 1990	Substantially Equivalent	AMERICAN ORTHODONTICS
K894477	INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM	Jan 10, 1990	Substantially Equivalent	COSMEDENT, INC.
K895798	SILCOT COPAL CAVITY VARNISH	Dec 21, 1989	Substantially Equivalent	SPECIALITES SEPTODONT
K892453	KULZER GLAS-IONOMER CEMENT	Dec 04, 1989	Substantially Equivalent	KULZER, INC.
K894219	TEMP BOND NE	Sep 18, 1989	Substantially Equivalent	KERR CORPORATION (DANBURY)
K891607	DENTANURSE	Aug 11, 1989	Substantially Equivalent	THE IRISH SCENE
K884652	OCTYLDENT	May 24, 1989	Substantially Equivalent	CRX MEDICAL, INC.
K890623	FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT	Apr 17, 1989	Substantially Equivalent	MACROCHEM CORP.
K890608	FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT	Apr 17, 1989	Substantially Equivalent	MACROCHEM CORP.
K885007	CIMPAT S TEMPORARY DENTAL CEMENT	Mar 01, 1989	Substantially Equivalent	SPECIALITES SEPTODONT
K882417	POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT	Feb 13, 1989	Substantially Equivalent	MILTON HODOSH, M.D.
K884475	CHELON-FIL	Dec 05, 1988	Substantially Equivalent	ESPE GMBH (US)
K884081	INTERIM, TEMPORARY CEMENT	Dec 02, 1988	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K883770	RESUBMITTED EMA DENTIN CEMENT	Nov 30, 1988	Substantially Equivalent	G-C INTL. CORP.
K883698	ZINC OXIDE EUGENOL TEMPORARY CEMENT	Nov 29, 1988	Substantially Equivalent	E&D DENTAL MANUFACTURING CO.
K881422	COE PAK AUTO MIX, REGULAR OR HARD SET	Oct 31, 1988	Substantially Equivalent	COE LABORATORIES, INC.
K881918	LIGHT-CURED ZIONOMER CEMENT	Jul 15, 1988	Substantially Equivalent	DEN-MAT CORP.
K881914	COVER UP	Jul 15, 1988	Substantially Equivalent	PARKELL
K881890	PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT	Jul 15, 1988	Substantially Equivalent	SPECIALITES SEPTODONT
K881661	IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT	Jun 07, 1988	Substantially Equivalent	SPECIALITES SEPTODONT
K880251	KERR XR IONOMER	Jun 01, 1988	Substantially Equivalent	KERR CORPORATION (DANBURY)
K880250	KERR XR BOND	Jun 01, 1988	Substantially Equivalent	KERR CORPORATION (DANBURY)
K880848	FUJI CAP II CAPSULE & APPLIER	May 16, 1988	Substantially Equivalent	G-C INTL. CORP.
K880685	PORCELITE DUAL CURE CEMENT	May 11, 1988	Substantially Equivalent	KERR CORPORATION (DANBURY)
K874788	KETAC-BOND APLICAP	Apr 12, 1988	Substantially Equivalent	ESPE GMBH (US)
K874458	PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER	Mar 18, 1988	Substantially Equivalent	LUSTGARTEN MULTI-TECH INTERNATIONAL, INC.
K872984	KETAC-CONDITIONER	Mar 09, 1988	Substantially Equivalent	ESPE GMBH (US)
K874945	CEMENT LINER	Feb 19, 1988	Substantially Equivalent	DENTSPLY INTL.
K874500	GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM.	Feb 18, 1988	Substantially Equivalent	HARRY J. BOSWORTH CO.
K873356	INSURE PORCELAIN VENEER BONDING SYSTEM	Dec 29, 1987	Substantially Equivalent	COSMEDENT, INC.
K871562	IONOCAL	May 20, 1987	Substantially Equivalent	FOREMOST DENTAL MFG., INC.
K864720	LIGHT-CURED PERIODONTAL DRESSING	Apr 07, 1987	Substantially Equivalent	DENTSPLY INTL.
K870211	BONDEX* GLASS IONOMER CEMENT	Mar 18, 1987	Substantially Equivalent	JOHNSON & JOHNSON PROFESSIONALS, INC.
K870334	BOSTON POST CEMENT	Feb 19, 1987	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K870209	NEXADENT (DENTAL CEMENT)	Feb 19, 1987	Substantially Equivalent	BIONEXUS, INC.
K864898	FOREMOST DENTIN ADHESIVE	Feb 12, 1987	Substantially Equivalent	FOREMOST DENTAL MFG., INC.
K864725	MODI. DICOR CASTABLE CERAMIC/ALL PORCELAIN BRIDGES	Jan 21, 1987	Substantially Equivalent	DENTSPLY INTL.
K864270	3M GLASS IONOMER LINER	Dec 16, 1986	Substantially Equivalent	3M COMPANY
K863141	KULZER GLASS IONOMER LINER	Aug 26, 1986	Substantially Equivalent	SHOFU DENTAL CORP.
K862280	SHOFU LINING CEMENT	Jun 23, 1986	Substantially Equivalent	SHOFU DENTAL CORP.
K861685	SUPERLON (UNILON) CARBOXYLATE CEMENT	May 19, 1986	Substantially Equivalent	CARLISLE LABORATORIES, INC.
K861005	GLASIONOMER BASE CEMENT	Apr 25, 1986	Substantially Equivalent	SHOFU DENTAL CORP.
K855211	PANAVIA EX, A DENTAL ADHESIVE	Mar 13, 1986	Substantially Equivalent	KURARAY CO.
K853091	CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE	Jan 21, 1986	Substantially Equivalent	PSP DENTAL CO., LTD.
K853090	CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO	Jan 21, 1986	Substantially Equivalent	PSP DENTAL CO., LTD.
K853447	POLYCARB WATER SET	Oct 16, 1985	Substantially Equivalent	PULPDENT CORP. OF AMERICA
K852196	ZIONOMER CEMENT	Jun 20, 1985	Substantially Equivalent	DEN-MAT CORP.
K851468	76 EMA LINING CEMENT	May 01, 1985	Substantially Equivalent	G-C INTL. CORP.
K850913	GLAS IONOMER CEMENT	Apr 10, 1985	Substantially Equivalent	SHOFU DENTAL CORP.
K844846	ESPE KETAC-CEM RADIOPAQUE	Mar 25, 1985	Substantially Equivalent	ESPE GMBH (US)
K843566	KETAC-SILVER	Dec 06, 1984	Substantially Equivalent	ESPE GMBH (US)
K842995	EMA LIV CENERA DENTAL CEMENT	Oct 30, 1984	Substantially Equivalent	INT'L CORP.
K842994	EMA FREEGENOL DENTAL CEMENT	Oct 18, 1984	Substantially Equivalent	INT'L CORP.
K840407	KERR RESIN BONDED BRIDGE CEMENT	May 21, 1984	Substantially Equivalent	SYBRON CORP.
K841195	GLAS IONOMER CEMENT	May 14, 1984	Substantially Equivalent	SHOFU DENTAL CORP.
K841196	HY-BOND ZINC OXIDE EUGENOL TEMP.	May 11, 1984	Substantially Equivalent	SHOFU DENTAL CORP.
K830113	SEPTOPACK	May 09, 1983	Substantially Equivalent	NORTH PACIFIC DENTAL, INC.
K830440	DENTA PLAST	Apr 28, 1983	Substantially Equivalent	DENTA, INC.
K830117	ENDOMET	Mar 01, 1983	Substantially Equivalent	NORTH PACIFIC DENTAL, INC.
K830107	SELFAST	Feb 18, 1983	Substantially Equivalent	NORTH PACIFIC DENTAL, INC.
K823935	MICRO JOIN, CROWN & BRIDGE ADHESIVE	Feb 07, 1983	Substantially Equivalent	SCI-PHARM, INC.
K823795	EVERBOND GLASS IONOMER CEMENT	Jan 26, 1983	Substantially Equivalent	SYBRON CORP.
K821824	TEM-STIK	Jul 06, 1982	Substantially Equivalent	CORALITE DENTAL PRODUCTS, INC.
K821326	CUTTER BOND POLYCARBOXYLATE CEMENT	May 28, 1982	Substantially Equivalent	CUTTER LABORATORIES, INC.
K813532	CUTTERBOND ZINC PHOSPHATE CEMENT	Mar 02, 1982	Substantially Equivalent	CUTTER LABORATORIES, INC.
K813380	CAVIDENTIN	Feb 24, 1982	Substantially Equivalent	BITAN INT'L MARKETING CO.
K812858	CHEMFIL	Dec 31, 1981	Substantially Equivalent	DENTSPLY INTL.
K812532	TEMP-FILL	Oct 14, 1981	Substantially Equivalent	MADRID USO, JR., D.D.S.
K812568	CAVITRON	Sep 25, 1981	Substantially Equivalent	G-C INTL. CORP.
K812115	KETAC-CHEM	Aug 31, 1981	Substantially Equivalent	ESPE-PREMIER SALES CO.
K811521	FUJI IONOMER TYPE I & II	Jun 26, 1981	Substantially Equivalent	G-C INTL. CORP.
K810765	HY-BOND ZINC PHOSPHATE CEMENT	Jun 12, 1981	Substantially Equivalent	SHOFU DENTAL CORP.
K810764	HY-BOND POLYCARBOXYLATE CEMENT	Jun 12, 1981	Substantially Equivalent	SHOFU DENTAL CORP.
K810545	PCA PERIOCARE PERIODONTAL DRESSING	Mar 24, 1981	Substantially Equivalent	PULPDENT CORP. OF AMERICA
K810026	DENTAL ENDODONTIC CEMENT	Jan 28, 1981	Substantially Equivalent	WITECH LABORATORY
K802662	POLYCARBONATE TEMPORARY CEMENT	Dec 16, 1980	Substantially Equivalent	BUFFALO DENTAL MFG. CO., INC.
K802819	KETAC-CEM IN REF. TO K802048	Nov 24, 1980	Substantially Equivalent	ESPE DENTAL PRODUCTS
K801227	SILICAP	Aug 12, 1980	Substantially Equivalent	VIVADENT (USA), INC.
K801236	REIGNING EPOXY RESIN CEMENT	Jul 08, 1980	Substantially Equivalent	OKI SHIKS USA LTD.
K801229	BONDALCAP (CARBOXYLATE)	Jun 04, 1980	Substantially Equivalent	VIVADENT (USA), INC.
K801228	BONDALCAP (SILICO-PHOSPHATE)	Jun 04, 1980	Substantially Equivalent	VIVADENT (USA), INC.
K791160	DENTALEEN	Feb 21, 1980	Substantially Equivalent	DENPAC CORP.
K800060	PROVIT	Jan 23, 1980	Substantially Equivalent	PARKER LABORATORIES, INC.
K790593	DENTAL CEMENT, ZINC PHOSPHATE	Jun 15, 1979	Substantially Equivalent	WALLACE A. ERICKSON & CO.
K790586	CHEMBOND	May 16, 1979	Substantially Equivalent	L.D. CAULK CO.
K790832	KETAC APPLIC-CAPSULES	Apr 30, 1979	Unknown	ESPE GMBH (US)
K790127	CEMENT, CERAMCO	Feb 26, 1979	Substantially Equivalent	JOHNSON & JOHNSON PROFESSIONALS, INC.
K781281	CEMENT, DENTAL/CAVITY LINER	Aug 21, 1978	Substantially Equivalent	STAR DENTAL MFG. CO.
K780301	CAULK TYLOK	Feb 28, 1978	Substantially Equivalent	L.D. CAULK CO.
K771114	NEUTROCIM	Jan 04, 1978	Substantially Equivalent	SEPTODONT, INC.
K771481	TONGUE BLADE HOLDER	Aug 19, 1977	Substantially Equivalent	WELCH ALLYN, INC.
K771451	SCUTABOND	Aug 16, 1977	Substantially Equivalent	PREMIER DENTAL PRODUCTS CO.
K770923	ESPETEMP (TEMP. CEMENT)	Jun 01, 1977	Substantially Equivalent	ESPE GMBH (US)
K770067	CYANOBOND	Jan 25, 1977	Substantially Equivalent	PARKER LABORATORIES, INC.
K761355	SELFAST	Jan 03, 1977	Substantially Equivalent	SEPTODONT, INC.
K761354	CIMPAT (PINK AND WHITE)	Jan 03, 1977	Substantially Equivalent	SEPTODONT, INC.
K760978	ZINC CEMENT	Nov 15, 1976	Substantially Equivalent	ADP INTL., INC.
K760239	CEMENT, ULTRA-BOND	Jul 26, 1976	Substantially Equivalent	ORATEC DENTAL PRODUCTS

FEI Numbers

This FDA classification entry is associated with 142 FEI numbers. Click on an entry to view related FDA registrations.

1000121639: 13 registrations

1000137528: 104 registrations

1000231788: 50 registrations

1000254146: 7 registrations

1000272892: 17 registrations

1000293792: 20 registrations

1000477999: 10 registrations

1000486347: 11 registrations

1000492377: 7 registrations

1000554802: 31 registrations

1013257: 6 registrations

1044031: 37 registrations

1215305: 79 registrations

1250045: 45 registrations

1281412: 38 registrations

1316092: 17 registrations

1410097: 126 registrations

1413475: 53 registrations

1420052: 78 registrations

1420089: 58 registrations

1450653: 53 registrations

1712259: 18 registrations

1718912: 102 registrations

1721647: 24 registrations

2018957: 98 registrations

2020493: 56 registrations

2022039: 55 registrations

2024312: 150 registrations

2027375: 22 registrations

2126683: 48 registrations

2183301: 191 registrations

2241860: 22 registrations

2411797: 47 registrations

2429849: 35 registrations

2433629: 27 registrations

2511556: 113 registrations

2515379: 99 registrations

2523320: 75 registrations

2647456: 12 registrations

2916735: 29 registrations

2921595: 65 registrations

3000209941: 62 registrations

3000368601: 106 registrations

3000719964: 98 registrations

3001027751: 15 registrations

3001236822: 8 registrations

3001746544: 72 registrations

3002574147: 37 registrations

3002718942: 129 registrations

3002729120: 30 registrations

3002789526: 26 registrations

3002806620: 35 registrations

3002806930: 78 registrations

3002807050: 47 registrations

3002807052: 50 registrations

3002807420: 38 registrations

3002807757: 3 registrations

3002808149: 74 registrations

3002808289: 76 registrations

3002808636: 93 registrations

3002811563: 20 registrations

3003120666: 37 registrations

3003449480: 25 registrations

3003487388: 17 registrations

3003621174: 21 registrations

3003667632: 34 registrations

3003769089: 4 registrations

3003775534: 7 registrations

3004130302: 17 registrations

3004140838: 37 registrations

3004146043: 6 registrations

3004150030: 41 registrations

3004425647: 57 registrations

3004569445: 13 registrations

3004586882: 36 registrations

3004724816: 17 registrations

3004727093: 79 registrations

3004966444: 86 registrations

3004967419: 8 registrations

3005138409: 5 registrations

3005174370: 52 registrations

3005176727: 41 registrations

3005628474: 14 registrations

3005907356: 25 registrations

3006066614: 519 registrations

3006113314: 28 registrations

3006238481: 1 registration

3006316962: 18 registrations

3006349398: 19 registrations

3006367836: 9 registrations

3006444232: 20 registrations

3006644229: 2 registrations

3006665149: 3 registrations

3006694515: 34 registrations

3006805063: 12 registrations

3007054491: 26 registrations

3007210751: 18 registrations

3007577370: 21 registrations

3007743883: 21 registrations

3008320092: 18 registrations

3008524225: 26 registrations

3008582406: 20 registrations

3008822460: 45 registrations

3008898734: 22 registrations

3008912871: 85 registrations

3009496224: 106 registrations

3010002722: 26 registrations

3010138769: 36 registrations

3010419931: 59 registrations

3010605677: 176 registrations

3011649314: 85 registrations

3011689956: 141 registrations

3011824442: 116 registrations

3011944170: 6 registrations

3012187973: 201 registrations

3012354669: 33 registrations

3012421607: 606 registrations

3012441963: 9 registrations

3012494290: 762 registrations

3012502601: 33 registrations

3012627824: 85 registrations

3013410675: 17 registrations

3013557697: 18 registrations

3013755719: 75 registrations

3014423939: 15 registrations

3014615644: 28 registrations

3014683120: 127 registrations

3015128224: 17 registrations

3015272949: 57 registrations

3016447764: 19 registrations

3016505723: 2 registrations

3017674095: 12 registrations

3018507299: 33 registrations

3022296393: 22 registrations

3026297922: 481 registrations

3027241817: 11 registrations

3030447506: 78 registrations

3030648980: 3 registrations

3032312561: 12 registrations

3032378317: 19 registrations

4108: 6 registrations

4321: 17 registrations