Product Code: KLE FDA class 2 21 CFR 872.3200

Agent, Tooth Bonding, Resin

Dental

A Resin Tooth Bonding Agent is a dental adhesive material used to bond restorative resins, composite materials, and other dental materials to tooth structure, providing a durable interface between the natural tooth surface and the restoration. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KLE and it is regulated under 21 CFR 872.3200 in the Dental specialty. This device is eligible for third-party review.

View on FDA

510(k)s

411

FEI Numbers

133

Registration Numbers

133

Unique Applicants

147

Years Active

Basic Information

Product Code: KLE
Device Class: FDA class 2
Regulation Number: 872.3200
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 411 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242530	HF-Etchant Hydrofluoric Acid Etching Gel	Dec 20, 2024	Substantially Equivalent	Rizhao HuGe Biomaterials Company, Ltd.
K242749	TopCEM Ceramic Primer Ceramic Coupling Agent	Nov 08, 2024	Substantially Equivalent	Rizhao HuGe Biomaterials Company, Ltd.
K242675	FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)	Nov 01, 2024	Substantially Equivalent	Spident Co., Ltd.
K240153	Ceramic Etchant (HF-5 and HF-9)	Oct 02, 2024	Substantially Equivalent	Liaoning Upcera Co., Ltd
K241445	K-Bond Universal	Jul 22, 2024	Substantially Equivalent	Spident Co., Ltd.
K241056	Light Cure Adhesive	Jul 16, 2024	Substantially Equivalent	Sincera Technology (Changchun) Co., Ltd.
K240743	Peak Universal Bond	Mar 20, 2024	Substantially Equivalent	Ultradent Products, Inc.
K231039	CLEARFIL Universal Bond Quick 2	Dec 13, 2023	Substantially Equivalent	Kuraray Noritake Dental Inc.
K232978	DX. Bond V Dental Bonding Adhesive	Sep 22, 2023	Substantially Equivalent	Sino-Dentex Co., Ltd.
K231696	Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal	Aug 11, 2023	Substantially Equivalent	Prevest Denpro Limited
K230465	Hi-Bond Universal	May 22, 2023	Substantially Equivalent	Mediclus Co., LTD.
K230009	EZ Bond Universal	Mar 03, 2023	Substantially Equivalent	Meta Biomed Co., LTD.
K222830	Rainbow 360	Jan 12, 2023	Substantially Equivalent	Kerr Corporation
K221450	Phosphoric Acid Etching Gel	Sep 12, 2022	Substantially Equivalent	Rizhao HuGe Biomaterials Company, Ltd.
K222357	DenMat Glutaraldehyde Desensitizer	Aug 09, 2022	Substantially Equivalent	DenMat Holding, LLC
K221033	UniPrime A, UniPrime E, UniPrime E/C	Jul 06, 2022	Substantially Equivalent	S&C Polymer Silicon- und Composite Spezialitäten GmbH
K220804	Dia-X Bond Universal	Jun 15, 2022	Substantially Equivalent	Diadent Group International
K210804	Adhese Universal DC, Cention Primer	Jun 07, 2022	Substantially Equivalent	Ivoclar Vivadent, AG
K213965	BeautiBond Xtreme	Mar 18, 2022	Substantially Equivalent	Shofu Dental Corporation
K213401	DIAPLUS Universal	Jan 31, 2022	Substantially Equivalent	Diadent Group International
K213093	STEP-1 PumEtch	Jan 28, 2022	Substantially Equivalent	Rounding Third LLC
K210186	PacBond One	Jul 16, 2021	Substantially Equivalent	Pac-Dent, Inc.
K210945	Ultra SEP	Jul 08, 2021	Substantially Equivalent	Reliance Orthodontic Products, Inc
K203760	Tokuyama Universal Bond II	May 25, 2021	Substantially Equivalent	Tokuyama Dental Corporation
K192913	R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose	Jan 19, 2021	Substantially Equivalent	Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.
K200153	Bright Bond Universal	Oct 28, 2020	Substantially Equivalent	GENOSS Co., Ltd.
K200682	BZF-29	Oct 02, 2020	Substantially Equivalent	GC America Inc.
K201787	Light Cure Dental Adhesive	Sep 25, 2020	Substantially Equivalent	Rizhao HuGe Biomaterials Company, Ltd.
K200462	EtchPro Etching Gel	Sep 02, 2020	Substantially Equivalent	Belport Company, Inc., Gingi-Pak
K192392	DiaPlus	May 26, 2020	Substantially Equivalent	Diadent Group International
K192273	DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit	Feb 07, 2020	Substantially Equivalent	Diadent Group International
K183424	Ambar, Ambar APS, Ambar Universal APS	Dec 13, 2019	Substantially Equivalent	DentsCare LTDA
K191656	Zipbond	Dec 02, 2019	Substantially Equivalent	SDI Limited
K192961	ADH19	Oct 31, 2019	Substantially Equivalent	3M Deutschland GmbH
K191523	Visalys Restorative Primer	Oct 09, 2019	Substantially Equivalent	Kettenbach GmbH & Co. KG
K191524	Visalys Tooth Primer	Sep 29, 2019	Substantially Equivalent	Kettenbach GmbH & Co. KG
K183391	Novidia Universal Bond	Sep 24, 2019	Substantially Equivalent	Nobio Ltd.
K180917	GC Acrylic Primer	Nov 20, 2018	Substantially Equivalent	GC America Inc.
K182162	OptiBond eXTRa Universal	Nov 07, 2018	Substantially Equivalent	Kerr Corporation
K181910	BracePaste MTP Light Cure Primer	Oct 15, 2018	Substantially Equivalent	American Orthodontics
K181476	Prime&Bond active Universal Adhesive	Sep 28, 2018	Substantially Equivalent	Dentsply Sirona
K180803	BeautiBond Universal	Sep 26, 2018	Substantially Equivalent	Shofu Dental Corporation
K180802	Meta P&Bond	Aug 29, 2018	Substantially Equivalent	META BIOMED, CO., LTD.
K172953	Acid Etchant	Feb 06, 2018	Substantially Equivalent	American Orthodontics
K172977	Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel	Jan 16, 2018	Substantially Equivalent	Nanova Biomaterials Inc
K171226	TOKUYAMA UNIVERSAL BOND	Nov 28, 2017	Substantially Equivalent	Tokuyama Dental Corporation
K172176	Parkell Universal Adhesive	Nov 21, 2017	Substantially Equivalent	Parkell, Inc.
K172106	SHOFU MZ Primer Plus	Aug 31, 2017	Substantially Equivalent	Shofu Dental Corporation
K161077	RnD TE and RnD SE	Mar 17, 2017	Substantially Equivalent	Apex Dental Materials, Inc
K161891	HC Primer	Nov 21, 2016	Substantially Equivalent	Shofu Dental Corporation
K161042	CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack	Oct 25, 2016	Substantially Equivalent	Kuraray Noritake Dental, Inc.
K161051	All-Bond Universal w/BAC (not finalized)	Sep 09, 2016	Substantially Equivalent	Bisco, Inc.
K152243	One Coat 7 Universal	Dec 09, 2015	Substantially Equivalent	Coltene/Whaledent AG
K152110	e-1 etchants	Nov 20, 2015	Substantially Equivalent	E DENTAL PRODUCTS
K151619	Prime&Bond Elect Universal Dental Adhesive	Oct 30, 2015	Substantially Equivalent	DENTSPLY INTERNATIONAL INC.
K151518	BRUSH&BOND PLUS	Sep 18, 2015	Substantially Equivalent	Parkell, Inc.
K150703	CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)	Aug 13, 2015	Substantially Equivalent	KURARAY NORITAKE DENTAL INC.
K150933	iBond Universal & iBond Ceramic Primer	Jul 07, 2015	Substantially Equivalent	Heraeus Kulzer LLC, Mitsui Chemicals Group
K150696	Jade 37% Phosphoric Acid Etchant Gel	Jun 23, 2015	Substantially Equivalent	Dharma Research, Inc.
K143140	G-Premio BOND	Apr 20, 2015	Substantially Equivalent	GC AMERICA, INC.
K150164	Monobond Etch & Prime	Apr 03, 2015	Substantially Equivalent	IVOCLAR VIVADENT AG
K142848	EAZY PRIMER	Feb 24, 2015	Substantially Equivalent	Parkell, Inc.
K141839	PREMIER ETCH	Nov 17, 2014	Substantially Equivalent	PREMIER DENTAL PRODUCTS CO.
K140537	TENURE4G	Aug 20, 2014	Substantially Equivalent	DEN-MAT HOLDINGS, LLC
K141610	FUTURABOND M+	Aug 01, 2014	Substantially Equivalent	VOCO GMBH
K131734	ALL-BOND UNIVERSAL SC (NOT FINALIZED)	Apr 11, 2014	Substantially Equivalent	BISCO, INC.
K133318	ADHESE UNIVERSAL	Feb 11, 2014	Substantially Equivalent	IVOCLAR VIVADENT AG
K132923	FUSION SINGLE LINK	Jan 03, 2014	Substantially Equivalent	ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA
K133078	K-ETCHANT SYRINGE; NEEDLE TIP (E)	Dec 20, 2013	Substantially Equivalent	KURARAY NORITAKE DENTAL INC.
K132450	CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND	Nov 01, 2013	Substantially Equivalent	KURARAY NORITAKE DENTAL INC.
K131043	APEX UNIVERSAL ADHESIVE	Sep 10, 2013	Substantially Equivalent	APEX DENTAL MATERIALS, INC.
K131357	PEAK Z	Sep 06, 2013	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K131430	CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL	Aug 30, 2013	Substantially Equivalent	KURARAY NORITAKE DENTAL INC.
K131049	ZRP	Aug 27, 2013	Substantially Equivalent	APEX DENTAL MATERIALS, INC.
K131212	PREMIER CERAMIC PRIMER	Aug 26, 2013	Substantially Equivalent	PREMIER DENTAL PRODUCTS CO.
K131432	CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL	Aug 22, 2013	Substantially Equivalent	KURARAY NORITAKE DENTAL INC.
K131248	ETCH GEL	Jul 11, 2013	Substantially Equivalent	DMG AMERICA, LLC
K130486	FUTURABOND UNIVERSAL	Jun 20, 2013	Substantially Equivalent	VOCO GMBH
K122522	DENTOETCH QUICKBOND BOND ACTIVATOR	Mar 19, 2013	Substantially Equivalent	ITENA CLINICAL
K123278	IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF	Dec 07, 2012	Substantially Equivalent	HERAEUS KULZER, LLC
K123119	CERARESIN BOND	Nov 28, 2012	Substantially Equivalent	SHOFU DENTAL CORPORATION
K120620	CLEAN AND BOOST	May 31, 2012	Substantially Equivalent	APEX DENTAL MATERIALS, INC.
K120767	ES BOND	May 24, 2012	Substantially Equivalent	SPIDENT CO., LTD.
K120213	ETCH-RITE SUPREME	Mar 30, 2012	Substantially Equivalent	PULPDENT CORPORATION
K112597	SEITY 37% PHOSPHORIC ACID ETCHANT GEL	Dec 07, 2011	Substantially Equivalent	MYCONE DENTAL SUPPLY CO., INC.
K112118	DREAMBOND	Nov 17, 2011	Substantially Equivalent	BISCO, INC.
K111980	CLEARFIL TRI-S BOND PLUS	Oct 14, 2011	Substantially Equivalent	KURARAY AMERICA, INC.
K111975	CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK	Oct 14, 2011	Substantially Equivalent	KURARAY MEDICAL INC.
K111876	Z BOND, PRELUDE ONE	Sep 21, 2011	Substantially Equivalent	DANVILLE MATERIALS, INC.
K110403	PROLINK ADHESIVES (PROLINK, PROLINK SE)	Sep 08, 2011	Substantially Equivalent	SILMET LTD.
K111431	B1P ADHESIVE	Aug 01, 2011	Substantially Equivalent	PENTRON CLINICAL
K110302	ADHESIVE EXL-759	May 19, 2011	Substantially Equivalent	3M ESPE AG
K110252	BEAUTIBOND MULTI PR PLUS	May 13, 2011	Substantially Equivalent	SHOFU DENTAL CORP.
K110235	BEAUTIBOND MULTI	May 13, 2011	Substantially Equivalent	SHOFU DENTAL CORP.
K102254	DMP SINGLE BONDING	Nov 23, 2010	Substantially Equivalent	DMP LTD
K102844	ALL-BOUND 3	Oct 29, 2010	Substantially Equivalent	BISCO, INC.
K101485	ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E	Aug 26, 2010	Substantially Equivalent	BISCO, INC.
K101423	OPTIBOND XTR	Jul 30, 2010	Substantially Equivalent	KERR CORPORATION
K100752	PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)	Jul 16, 2010	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K100347	OPTIBOND SE	Apr 30, 2010	Substantially Equivalent	KERR CORPORATION
K093014	AMERICAN DENTAL PRODUCTS SE BONDEASY	Apr 16, 2010	Substantially Equivalent	AMERICAN DENTAL PRODUCTS, INC.
K093744	EXCITE F AND EXCITE DSC	Mar 10, 2010	Substantially Equivalent	IVOCLAR VIVADENT, INC.
K092616	ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045	Oct 21, 2009	Substantially Equivalent	CAO GROUP, INC.
K091705	PRIMER PLUS	Aug 28, 2009	Substantially Equivalent	BISCO, INC.
K091300	ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079	Jul 23, 2009	Substantially Equivalent	CAO GROUP, INC.
K090941	ADHESE ONE F	Jul 17, 2009	Substantially Equivalent	IVOCLAR VIVADENT, INC.
K090826	MONOBOND PLUS	May 11, 2009	Substantially Equivalent	IVOCLAR VIVADENT, INC.
K090106	PRELUDE ONE	Mar 31, 2009	Substantially Equivalent	DANVILLE MATERIALS, INC.
K083652	IBOND TOTAL ETCH	Jan 21, 2009	Substantially Equivalent	HERAEUS KULZER GMBH
K082744	BEAUTIBOND	Dec 11, 2008	Substantially Equivalent	SHOFU DENTAL CORP.
K082753	FUTURABOND M/FUTURABOND M SINGLE DOSE	Nov 24, 2008	Substantially Equivalent	VOCO GMBH
K082768	G-BOND PLUS	Oct 21, 2008	Substantially Equivalent	GC AMERICA, INC.
K072480	GENERATION 8 SE ADHESIVE	Nov 21, 2007	Substantially Equivalent	PENTRON CLINICAL TECHNOLOGIES
K071688	RELIANCE S.E.P.	Sep 07, 2007	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K071500	NANO-BOND II ADHESIVE SYSTEM	Aug 10, 2007	Substantially Equivalent	PENTRON CLINICAL TECHNOLOGIES
K071131	UNO	Jul 25, 2007	Substantially Equivalent	3M ESPE AG DENTAL PRODUCTS
K071260	HERMES BOND 3	Jul 17, 2007	Substantially Equivalent	3M ESPE AG DENTAL PRODUCTS
K071452	FL BOND II	Jul 09, 2007	Substantially Equivalent	SHOFU DENTAL CORP.
K070723	FUTURABOND DC/SINGLE DOSE	Jun 07, 2007	Substantially Equivalent	VOCO GMBH
K070956	SEA2 SELF ETCH ADHESIVE	May 22, 2007	Substantially Equivalent	3M ESPE DENTAL PRODUCTS
K070646	ADHESE ONE	May 11, 2007	Substantially Equivalent	IVOCLAR VIVADENT, INC.
K070413	ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028	Apr 26, 2007	Substantially Equivalent	CAO GROUP, INC.
K070215	TOKUYAMA BOND FORCE	Mar 30, 2007	Substantially Equivalent	TOKUYAMA DENTAL CORPORATION
K063444	TOTAL ETCH BONDING AGENT	Mar 20, 2007	Substantially Equivalent	DMG USA, INC.
K070538	XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE	Mar 14, 2007	Substantially Equivalent	DENTSPLY INTL.
K063780	ACE BOND SE	Jan 19, 2007	Substantially Equivalent	BISCO, INC.
K063558	PEAK SE, MODEL 5135	Dec 14, 2006	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K063557	PEAK BOND, MODEL 5133	Dec 12, 2006	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K063062	HKBOND 2006	Dec 01, 2006	Substantially Equivalent	HERAEUS KULZER, INC.
K062713	ADHESIVE DC ACTIVATOR	Nov 02, 2006	Substantially Equivalent	IVOCLAR VIVADENT, INC.
K061998	PREMIER SELF-ETCHING BOND ENHANCER	Oct 04, 2006	Substantially Equivalent	PREMIER DENTAL PRODUCTS CO.
K062382	CLEARFIL DC BOND	Sep 27, 2006	Substantially Equivalent	KURARAY MEDICAL INC.
K061611	BOSWORTH DENTIN RESIN	Sep 11, 2006	Substantially Equivalent	HARRY J. BOSWORTH CO.
K060882	EXCEL BOND DC, MODEL 28-200100	Sep 01, 2006	Substantially Equivalent	J. MORITA USA, INC.
K061981	SURPASS	Jul 31, 2006	Substantially Equivalent	APEX DENTAL MATERIALS, INC.
K061322	PORCELAIN PRIMER	Jun 02, 2006	Substantially Equivalent	J. MORITA USA, INC.
K060684	ADPER PROMPT, ADPER PROMPT L-POP	Apr 24, 2006	Substantially Equivalent	3M ESPE AG DENTAL PRODUCTS
K060469	OPTIBOND ALL-IN-ONE	Mar 28, 2006	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K053103	INTERFACE	Feb 01, 2006	Substantially Equivalent	APEX DENTAL MATERIALS, INC.
K053392	FUTURABOND NR SINGLE DOSE	Dec 15, 2005	Substantially Equivalent	VOCO GMBH
K052699	VERSA-LINK PORCELAIN BONDING SYSTEM	Nov 16, 2005	Substantially Equivalent	SULTAN CHEMISTS, INC.
K052501	MULTIPLE RESIN TOOTH BONDING AGENT	Oct 21, 2005	Substantially Equivalent	COSMEDENT, INC.
K052189	REVENEER CERAMIC REPAIR SYSTEM	Oct 17, 2005	Substantially Equivalent	SCHUTZ-DENTAL GMBH
K051796	CLEARFIL TRI-S BOND SINGLE DOSE	Aug 09, 2005	Substantially Equivalent	KURARAY MEDICAL KURASHIKI PLANT
K051707	ECLIPSE BONDING AGENT	Jul 15, 2005	Substantially Equivalent	DENTSPLY INTL.
K051463	XENO ADHESIVE WITH ACTIVATOR	Jul 12, 2005	Substantially Equivalent	DENTSPLY INTL.
K051050	SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092	Jun 29, 2005	Substantially Equivalent	SCHUTZ-DENTAL GMBH
K051006	IBOND NEXT GENERATION	Jun 07, 2005	Substantially Equivalent	HERAEUS KULZER GMBH
K050647	ALL-IN-ONE	Apr 20, 2005	Substantially Equivalent	BISCO, INC.
K050331	ADHESIVE 1	Mar 24, 2005	Substantially Equivalent	SOUTHERN DENTAL INDUSTRIES, INC.
K043170	BOSWORTH BOND	Feb 25, 2005	Substantially Equivalent	HARRY J. BOSWORTH CO.
K050386	PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM	Feb 23, 2005	Substantially Equivalent	DENTSPLY INTERNATIONAL
K043043	HERMES BOND 2	Jan 10, 2005	Substantially Equivalent	3M ESPE AG DENTAL PRODUCTS
K043562	BC PLUS	Jan 03, 2005	Substantially Equivalent	VERICOM CO., LTD.
K042913	CLEARFIL TRI-S BOND	Nov 26, 2004	Substantially Equivalent	KURARAY MEDICAL INC.
K042806	QUADRANT UNIT-1-BOND	Nov 24, 2004	Substantially Equivalent	CAVEX HOLLAND B.V.
K042614	S&C-SELF ETCH PR-BOND	Nov 22, 2004	Substantially Equivalent	S & C POLYMER GMBH
K041680	ORAJEL ADVANCED TOOTH DESENSITIZER	Nov 10, 2004	Substantially Equivalent	DEL PHARMACEUTICALS, INC.
K042670	FUTURABOND NR	Nov 01, 2004	Substantially Equivalent	VOCO GMBH
K040079	M.L. PRIMER	Sep 09, 2004	Substantially Equivalent	SHOFU DENTAL CORP.
K041960	COMPOSITE/COMPOMER REPAIR KIT	Aug 30, 2004	Substantially Equivalent	DMG USA, INC.
K041471	G-BOND	Jun 29, 2004	Substantially Equivalent	GC AMERICA INC.
K040952	PRELUDE	Jun 29, 2004	Substantially Equivalent	DANVILLE MATERIALS, INC.
K041343	XENO NM LIGHT CURED DENTAL ADHESIVE	Jun 16, 2004	Substantially Equivalent	DENTSPLY INTERNATIONAL
K040857	MODIFICATION TO ADPER PROMPT	May 10, 2004	Substantially Equivalent	3M ESPE AG DENTAL PRODUCTS
K033974	HERMES BOND	Feb 06, 2004	Substantially Equivalent	3M ESPE AG DENTAL PRODUCTS
K033938	CLEARFIL PROTECT BOND	Jan 29, 2004	Substantially Equivalent	KURARAY MEDICAL INC.
K033760	ONE COAT SE BOND	Jan 23, 2004	Substantially Equivalent	COLTENE/WHALEDENT INC.
K032953	EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT	Dec 10, 2003	Substantially Equivalent	PULPDENT CORPORATION
K032626	PERMAQUICK SE BONDING SYSTEM	Dec 03, 2003	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K032179	COMP. E	Sep 09, 2003	Substantially Equivalent	PARKELL, INC.
K031915	PULPDENT ETCH-RITE ROYALE	Aug 05, 2003	Substantially Equivalent	PULPDENT CORPORATION
K031444	OPTIBOND FL	Jul 02, 2003	Substantially Equivalent	KERR DENTAL MATERIALS CENTER
K030844	FINAL VARNISH LC	Jun 13, 2003	Substantially Equivalent	VOCO GMBH
K030743	ETCHANT 40%	May 09, 2003	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K024356	CLEARFIL SILANE KIT	Mar 26, 2003	Substantially Equivalent	KURARAY MEDICAL INC.
K023842	CLEARFIL SE BOND PLUS	Feb 11, 2003	Substantially Equivalent	KURARAY MEDICAL INC.
K023776	XENO III DENTAL ADHESIVE	Jan 23, 2003	Substantially Equivalent	DENTSPLY INTL.
K022973	ADHESIVE 14	Nov 22, 2002	Substantially Equivalent	AB ARDENT
K023042	PQ1	Oct 28, 2002	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K022612	IBOND GLUMA INSIDE	Oct 28, 2002	Substantially Equivalent	HERAEUS KULZER, INC.
K021427	CLEARFIL SA PRIMER	Jun 07, 2002	Substantially Equivalent	KURARAY MEDICAL INC.
K020514	PULPDENT GLAZE II	May 16, 2002	Substantially Equivalent	PULPDENT CORPORATION
K020570	SIMPLICITY	Apr 24, 2002	Substantially Equivalent	APEX DENTAL MATERIALS, INC.
K020499	BOND-3 ADHESIVE	Apr 22, 2002	Substantially Equivalent	JENERIC/PENTRON, INC.
K020303	XR PRIMER 2	Apr 19, 2002	Substantially Equivalent	KERR DENTAL MATERIALS CENTER
K020946	ADPER PROMPT	Apr 04, 2002	Substantially Equivalent	3M ESPE AG DENTAL PRODUCTS
K020239	TOUCH&BOND-PLUS	Mar 20, 2002	Substantially Equivalent	PARKELL, INC.
K014027	OPTIBOND SOLO PLUS 4	Feb 22, 2002	Substantially Equivalent	KERR DENTAL MATERIALS CENTER
K013543	BOND-1 C & B	Feb 22, 2002	Substantially Equivalent	JENERIC/PENTRON, INC.
K013997	UNIFIL BOND	Feb 20, 2002	Substantially Equivalent	GC AMERICA, INC.
K020050	ENAMEL BONDING SYSTEM	Feb 14, 2002	Substantially Equivalent	RITE-DENT MANUFACTURING CORP.
K013542	DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)	Feb 14, 2002	Substantially Equivalent	JENERIC/PENTRON, INC.
K013584	EXCITE SELF ETCH	Jan 28, 2002	Substantially Equivalent	IVOCLAR VIVADENT, INC.
K013519	SIMPLE	Jan 17, 2002	Substantially Equivalent	BISCO, INC.
K012082	OPTIBOND SOLO PLUS ACTIVATOR	Sep 20, 2001	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K012734	CLEARFIL NEW BOND	Sep 14, 2001	Substantially Equivalent	KURARAY MEDICAL INC.
K012730	CLEARFIL PORCELAIN BOND ACTIVATOR	Sep 13, 2001	Substantially Equivalent	KURARAY MEDICAL INC.
K012729	CLEARFIL REPAIR	Sep 13, 2001	Substantially Equivalent	KURARAY MEDICAL INC.
K012442	MODIFICATION TO CLEARFIL SE BOND	Sep 10, 2001	Substantially Equivalent	KURARAY MEDICAL INC.
K012440	MODIFICATION TO CLEARFIL LINER BOND 2V	Sep 05, 2001	Substantially Equivalent	KURARAY MEDICAL INC.
K012436	MODIFICATION TO ALLOY PRIMER	Sep 04, 2001	Substantially Equivalent	KURARAY MEDICAL INC.
K012432	MODIFICATION TO CLEARFIL PHOTO BOND	Sep 04, 2001	Substantially Equivalent	KURARAY MEDICAL INC.
K012322	OPTIBOND 2	Aug 30, 2001	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K010547	VERTEX SEALAND L/C ORTHODONTIC SEALANT	Aug 16, 2001	Substantially Equivalent	APEX DENTAL MATERIALS, INC.
K010415	ISODAN	Jul 23, 2001	Substantially Equivalent	SPECIALITES SEPTODONT
K011490	MODIFICATION TO EXCITE	Jun 27, 2001	Substantially Equivalent	IVOCLAR NORTH AMERICA, INC.
K011167	XSE	May 17, 2001	Substantially Equivalent	3M COMPANY
K003293	EXCITE DSC	Feb 06, 2001	Substantially Equivalent	IVOCLAR NORTH AMERICA, INC.
K003011	SELF ETCH BONDING PRIMER	Nov 28, 2000	Substantially Equivalent	JENERIC/PENTRON, INC.
K003153	SOLOBOND PLUS	Nov 15, 2000	Substantially Equivalent	VOCO GMBH
K002502	CERAM-PRIME	Nov 08, 2000	Substantially Equivalent	S & C POLYMER GMBH
K001914	CLEARFIL REPAIR	Aug 10, 2000	Substantially Equivalent	KURARAY COMPANY, LTD.
K001494	MODIFICATION TO PROMPT L-POP	Jul 07, 2000	Substantially Equivalent	ESPE DENTAL AG
K000189	PQ1	May 11, 2000	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K000954	KERR GEL ETCHANT	Apr 28, 2000	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K994359	BOND 1 C & B	Mar 21, 2000	Substantially Equivalent	JENERIC/PENTRON, INC.
K994302	RESIN TOOTH BONDING AGENT	Feb 07, 2000	Substantially Equivalent	PARKELL, INC.
K993917	TOKUYAMA ONE-UP-BOND F	Feb 02, 2000	Substantially Equivalent	TOKUYAMA AMERICA, INC.
K993683	PULPDENT UNO-DUO	Dec 13, 1999	Substantially Equivalent	PULPDENT CORP.
K993013	SURE BOND	Nov 29, 1999	Substantially Equivalent	MIRADENT DISTRIBUTING CO., LLC.
K992838	ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE	Nov 15, 1999	Substantially Equivalent	BIOMAT SCIENCES, INC.
K992879	ECUSIT COMPOSITE REPAIR	Nov 09, 1999	Substantially Equivalent	DMG HAMBURG
K992985	GLUMA COMFORT BOND	Oct 14, 1999	Substantially Equivalent	HERAEUS KULZER, INC.
K992292	GLUMA COMFORT BOND + DESENSITIZER	Oct 01, 1999	Substantially Equivalent	HERAEUS KULZER, INC.
K992048	MODIFICATION OF PROMPT L-POP	Aug 16, 1999	Substantially Equivalent	ESPE DENTAL AG
K991808	OPTIBOND SOLO PLUS 2	Jul 09, 1999	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K990534	EXCITE	Mar 19, 1999	Substantially Equivalent	IVOCLAR NORTH AMERICA, INC.
K990498	OPTIBOND SOLO PLUS	Mar 08, 1999	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K984503	ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000	Feb 26, 1999	Substantially Equivalent	WALLACE A. ERICKSON & CO.
K990143	GLUMA ONE BOND	Feb 25, 1999	Substantially Equivalent	HERAEUS KULZER, INC.
K990040	CLEARFIL SE BOND	Feb 04, 1999	Substantially Equivalent	KURARAY CO.
K984246	PROMPT L-POP	Jan 08, 1999	Substantially Equivalent	ESPE DENTAL AG
K983414	EVERBOND	Dec 16, 1998	Substantially Equivalent	ESPE DENTAL AG
K983668	MODIFICATION OF PQ1	Nov 30, 1998	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K983545	QUADRANT UNIBOND	Nov 18, 1998	Substantially Equivalent	CAVEX HOLLAND B.V.
K982394	PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM	Sep 21, 1998	Substantially Equivalent	DENTSPLY INTL.
K982007	TRUBYTE DENTURE BOND DENTURE BONDING AGENT	Jul 22, 1998	Substantially Equivalent	DENTSPLY INTL.
K981514	GC FUJI BOND LC	Jun 16, 1998	Substantially Equivalent	GC AMERICA, INC.
K981383	ALLOYBOND	Jun 16, 1998	Substantially Equivalent	SOUTHERN DENTAL INDUSTRIES, INC.
K974906	ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM	Mar 24, 1998	Substantially Equivalent	COLTENE/WHALEDENT INC.
K980539	SOLOBOND M	Mar 23, 1998	Substantially Equivalent	VOCO GMBH
K973002	HURRISEAL DENTIN DESENSITIZER	Mar 23, 1998	Substantially Equivalent	CHENG & ASSOC., INC.
K974786	PREPQUICK	Mar 03, 1998	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K973285	D/SENSE-T	Feb 25, 1998	Substantially Equivalent	CENTRIX, INC.
K974390	GLUMA ONE BOND	Feb 04, 1998	Substantially Equivalent	HERAEUS KULZER, INC.
K974486	CLEARFIL LINER BOND 2V	Jan 29, 1998	Substantially Equivalent	KURARAY AMERICA, INC.
K974283	PQ 1	Jan 29, 1998	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K974089	ALLOY PRIMER	Dec 17, 1997	Substantially Equivalent	KURARAY AMERICA, INC.
K973092	STAE	Dec 08, 1997	Substantially Equivalent	SOUTHERN DENTAL INDUSTRIES, INC.
K973185	AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE	Nov 14, 1997	Substantially Equivalent	AMERICAN DENTAL PRODUCTS, INC.
K973245	TOKUSO REBASE MR. BOND	Oct 07, 1997	Substantially Equivalent	TOKUYAMA AMERICA, INC.
K971733	2 BOND 2	Oct 02, 1997	Substantially Equivalent	HERAEUS KULZER, INC.
K972101	SOLITAIRE	Sep 29, 1997	Substantially Equivalent	HERAEUS KULZER, INC.
K972858	KERR NEXUS ONE BOTTLE ADHESIVE	Sep 26, 1997	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K973388	DENTIN CONDITIONING AND ADHESIVE (BOND 1)	Sep 12, 1997	Substantially Equivalent	JENERIC/PENTRON, INC.
K972421	EASY BOND	Aug 29, 1997	Substantially Equivalent	PARKELL, INC.
K972594	METALPRIMER II	Aug 26, 1997	Substantially Equivalent	GC AMERICA, INC.
K971121	ENCORE BOND	Jun 27, 1997	Substantially Equivalent	CENTRIX, INC.
K970848	SILOC SYSTEM	May 06, 1997	Substantially Equivalent	HERAEUS KULZER, INC.
K964867	HYBRID RESIN COMPOSITE	Apr 11, 1997	Substantially Equivalent	PARKELL, INC.
K964038	CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG	Apr 02, 1997	Substantially Equivalent	HERAEUS KULZER, INC.
K965138	DENTINSENSE B/C	Feb 14, 1997	Substantially Equivalent	CENTRIX, INC.
K964735	DENTINSENSE	Feb 05, 1997	Substantially Equivalent	CENTRIX, INC.
K964525	PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR	Jan 22, 1997	Substantially Equivalent	DENTSPLY INTL.
K964133	AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE	Jan 09, 1997	Substantially Equivalent	AMERICAN DENTAL PRODUCTS, INC.
K964140	GLUMA CONDITIONER	Nov 05, 1996	Substantially Equivalent	HERAEUS KULZER, INC.
K964000	BISFIL 2B	Nov 05, 1996	Substantially Equivalent	BISCO, INC.
K962812	GLUMA DESENSITIZER/GLUMA 3 PRIMER	Oct 07, 1996	Substantially Equivalent	HERAEUS KULZER, INC.
K962428	EBS (ESPE BONDING SYSTEM)	Sep 12, 1996	Substantially Equivalent	ESPE GMBH & CO. KG.
K962785	3M DENT SYSTEM	Aug 12, 1996	Substantially Equivalent	3M COMPANY
K962515	KERR ADVANCED ADHESIVE	Aug 01, 1996	Substantially Equivalent	KERR DENTAL MATERIALS CENTER
K962348	PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT	Jul 18, 1996	Substantially Equivalent	DENTSPLY INTL.
K960696	PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM	Jul 18, 1996	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K962277	SELF CURE BONDING AGENT	Jul 03, 1996	Substantially Equivalent	DENT ZAR, INC.
K961822	WET-PREP	Jun 11, 1996	Substantially Equivalent	BISCO, INC.
K960697	ULTRACID AND ULTRACID F DISINFECTING SOLUTION	May 06, 1996	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K960823	PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT	Apr 26, 1996	Substantially Equivalent	DENTSPLY INTL.
K960365	ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)	Mar 28, 1996	Substantially Equivalent	WALLACE A. ERICKSON & CO.
K955328	CONFI-BOND	Mar 28, 1996	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K960879	AMALGAMIBOND PLUS	Mar 22, 1996	Substantially Equivalent	PARKELL, INC.
K955740	GLUFLORMA	Feb 08, 1996	Substantially Equivalent	MIDWEST ORTHODONTIC MFG.
K955279	D-SENSE	Dec 28, 1995	Substantially Equivalent	CENTRIX, INC.
K954708	SILANE PRIMER	Oct 30, 1995	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K954133	AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER	Oct 30, 1995	Substantially Equivalent	AMERICAN DENTAL PRODUCTS, INC.
K953613	IMPERVA ENSURABOND	Oct 04, 1995	Substantially Equivalent	SHOFU DENTAL CORP.
K953612	IMPERVA FLUOROBOND	Oct 04, 1995	Substantially Equivalent	SHOFU DENTAL CORP.
K953504	MICROPRIME	Oct 03, 1995	Substantially Equivalent	DANVILLE ENGINEERING, INC.
K953405	HEMA-BENZ	Sep 27, 1995	Substantially Equivalent	HEALTH-DENT INTL., INC.
K953166	FUJI BOND LC	Sep 27, 1995	Substantially Equivalent	GC AMERICA, INC.
K953476	MULTI-PRIME AKA/MONO-PRIME	Sep 22, 1995	Substantially Equivalent	SILICON-UND COMPOSITE SPEZIALITATEN GMBH
K953859	BOND-IT DUAL CURE ACTIVATOR	Sep 07, 1995	Substantially Equivalent	JENERIC/PENTRON, INC.
K953592	REVOLUTION BOND	Sep 07, 1995	Substantially Equivalent	E&D DENTAL PRODUCTS, INC.
K953527	PERMUALUTE INDIRECT RESTORATIVE BONDING PRIMERS	Aug 29, 1995	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K952124	ABOND	Jun 20, 1995	Substantially Equivalent	PARKELL, INC.
K952123	MS EMULSION	Jun 20, 1995	Substantially Equivalent	PARKELL, INC.
K951867	PERMAQUIK BONDING PRIMER	May 23, 1995	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K951864	PRIME & BOND DIRECT COMPOSITE BONDING AGENT	May 23, 1995	Substantially Equivalent	DENTSPLY INTL.
K951583	PERMAQUIK BONDING PRIMER	May 12, 1995	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K951220	HEMA-GLU	May 12, 1995	Substantially Equivalent	HEALTH-DENT INTL., INC.
K950905	C&B-METABOND RADIOPAQUE POWDER	Apr 10, 1995	Substantially Equivalent	PARKELL, INC.
K950860	PERMALUTE	Mar 23, 1995	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K945604	ECLIPTOMER	Jan 03, 1995	Substantially Equivalent	BISCO, INC.
K945112	PULPDENT DUAL CURE UNFILLED BONDING RESIN	Dec 14, 1994	Substantially Equivalent	PULPDENT CORP.
K933360	GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER	Nov 22, 1994	Substantially Equivalent	MILES INC., DENTAL PRODUCTS
K943738	OPTIBOND-D	Sep 09, 1994	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K943373	PERMAGEN F/DC	Aug 23, 1994	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K943170	CLEARFIL LINER BOND 2	Aug 10, 1994	Substantially Equivalent	KURARAY COMPANY, LTD.
K943167	CLEARFIL NEW BOND	Aug 10, 1994	Substantially Equivalent	KURARAY COMPANY, LTD.
K943166	CLEARFIL LINER BOND SYSTEM	Aug 10, 1994	Substantially Equivalent	KURARAY COMPANY, LTD.
K943165	CLEARFIL PHOTO BOND	Aug 10, 1994	Substantially Equivalent	KURARAY COMPANY, LTD.
K942017	V-PRIMER	Jul 06, 1994	Substantially Equivalent	PARKELL, INC.
K942493	SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE SYSTEM	Jul 05, 1994	Substantially Equivalent	3M COMPANY
K941572	FLUORIDE-PSA PRIME/ADHESIVE	Jun 10, 1994	Substantially Equivalent	DENTSPLY INTL.
K940513	OPTIBOND	Apr 15, 1994	Substantially Equivalent	KERR CORPORATION (DANBURY)
K936222	DENTIN CONDITIONING AND ADHESIVE SYSTEM	Mar 15, 1994	Substantially Equivalent	JENERIC/PENTRON, INC.
K935961	GC FUJI COAT LC	Mar 10, 1994	Substantially Equivalent	GC AMERICA, INC.
K935735	ATTACHMENT BOND	Mar 07, 1994	Substantially Equivalent	HERAEUS KULZER, INC.
K936100	CLEARFIL LINER BOND 2	Feb 03, 1994	Substantially Equivalent	KURARAY INTL. CORP.
K934596	BISCO DUO LINK D/C LUTING COMPOSITE	Jan 26, 1994	Substantially Equivalent	BISCO, INC.
K934690	KERR OPTIBOND, MODIFICATION	Dec 30, 1993	Substantially Equivalent	KERR CORPORATION (DANBURY)
K931710	PULPDENT DENTAL BOND ENHANCER 2-B	Aug 24, 1993	Substantially Equivalent	PULPDENT CORP.
K932379	ALL-BOND(R) JR.	Jul 22, 1993	Substantially Equivalent	BISCO, INC.
K931870	BONDING RESIN PRODUCT LINE	Jul 22, 1993	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K931838	DENTHESIVE II	Jul 08, 1993	Substantially Equivalent	HERAEUS KULZER, INC.
K931812	NEW DENTINE ADHESIVE	Jul 08, 1993	Substantially Equivalent	DENTSPLY INTL.
K930504	NEW DENTIN PRIMER	May 27, 1993	Substantially Equivalent	DENTSPLY INTL.
K930989	PULPDENT UNFILLED DUAL CURE BONDING RESIN	Apr 20, 1993	Substantially Equivalent	PULPDENT CORP.
K924378	RESTOBOND 4	Mar 31, 1993	Substantially Equivalent	LEE PHARMACEUTICALS
K913581	WILDE ADHESIVE BONDING SYSTEM	Feb 26, 1993	Substantially Equivalent	WILDE-USA, INC.
K925404	CLEARFIL PORCELAIN BOND ACTIVATOR	Jan 11, 1993	Substantially Equivalent	KURARAY CO.
K924670	DENTIN RELIEF	Nov 23, 1992	Substantially Equivalent	PROFESSIONAL TECHNOLOGIES CORP.
K924181	POLIBOND	Oct 16, 1992	Substantially Equivalent	VOCO GMBH
K923842	BISCO UNIVERSAL BOND-3	Sep 29, 1992	Substantially Equivalent	BISCO, INC.
K923546	OPTIBOND	Sep 29, 1992	Substantially Equivalent	KERR CORPORATION (DANBURY)
K922615	COLTENE A.R.T. BOND	Aug 03, 1992	Substantially Equivalent	COLTENE/WHALEDENT INC.
K921701	DURAFILL BOND	Jun 09, 1992	Substantially Equivalent	HERAEUS KULZER, INC.
K920424	SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM	Mar 20, 1992	Substantially Equivalent	3M COMPANY
K915511	MIRAGE COMPLETE KIT AND MIRAGE ABC KIT	Mar 06, 1992	Substantially Equivalent	MIRAGE DENTAL SYSTEMS
K915830	PRISMA UNIVERSAL BOND(R) 3	Mar 02, 1992	Substantially Equivalent	DENTSPLY INTL.
K910069	SR-ISOSIT SPECTRA LINK SYSTEM	Mar 02, 1992	Substantially Equivalent	IVOCLAR NORTH AMERICA, INC.
K913965	ESPE(R) -SIL	Dec 04, 1991	Substantially Equivalent	ESPE GMBH (US)
K913946	IMPERVA DUAL	Dec 03, 1991	Substantially Equivalent	SHOFU DENTAL CORP.
K911282	PULPDENT ENAMEL BONDING AGENT	Sep 06, 1991	Substantially Equivalent	PULPDENT CORP.
K912707	CLEARFIL LINER BOND SYSTEM	Aug 20, 1991	Substantially Equivalent	KURARAY CO.
K912256	PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT	Jul 24, 1991	Substantially Equivalent	LEE PHARMACEUTICALS
K911525	TOKUSO LIGHT BOND	May 15, 1991	Substantially Equivalent	TOKUYAMA AMERICA, INC.
K910860	ALL-BOND 2	Apr 29, 1991	Substantially Equivalent	BISCO, INC.
K910628	ALL BOND LINER-F	Mar 29, 1991	Substantially Equivalent	BISCO, INC.
K905302	DENTHESIVE	Feb 26, 1991	Substantially Equivalent	KULZER, INC.
K904724	CONQUEST DIRECT FILLING COMPOSITE (DFC)	Dec 07, 1990	Substantially Equivalent	JENERIC/PENTRON, INC.
K904289	PERTAC UNIVERSAL BOND	Nov 01, 1990	Substantially Equivalent	ESPE GMBH (US)
K902744	DEGUFILL (TM) BOND	Aug 15, 1990	Substantially Equivalent	DEGUSSA AG
K901871	DEGUFILL (R) ADHESIVE	Aug 06, 1990	Substantially Equivalent	DEGUSSA AG
K901870	DEGUFILL (R) BOND	Aug 06, 1990	Substantially Equivalent	DEGUSSA AG
K901913	SYNTAC (DENTIN BONDING AGENT)	Jun 26, 1990	Substantially Equivalent	IVOCLAR NORTH AMERICA, INC.
K897009	PALFIQUE LIGHT BONDING AGENT	May 15, 1990	Substantially Equivalent	TOKUYAMA AMERICA, INC.
K900558	PERTAC BOND	Apr 10, 1990	Substantially Equivalent	ESPE GMBH (US)
K897020	ALL-BOND DENTIN BONDING SYSTEM	Mar 14, 1990	Substantially Equivalent	BISCO, INC.
K896659	SILANE	Feb 14, 1990	Substantially Equivalent	PULPDENT CORP.
K896655	9.6% HYDROFLUORIC ACID GEL	Feb 14, 1990	Substantially Equivalent	PULPDENT CORP.
K896382	MODIFIED GLUMA BONDING SYSTEM	Feb 01, 1990	Substantially Equivalent	HERAEUS KULZER, INC.
K895750	HEMA-PRIMER	Dec 21, 1989	Substantially Equivalent	PARKELL
K894315	RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT	Oct 31, 1989	Substantially Equivalent	LEE PHARMACEUTICALS
K894994	DENTIN BONDING SYSTEM	Oct 24, 1989	Substantially Equivalent	COSMEDENT, INC.
K894391	PVS DUAL CURE VENEER BONDING KIT	Sep 19, 1989	Substantially Equivalent	JELENKO CO.
K892003	ABRAKADABRA - DENTAL ADHESIVE SYSTEM	Jun 07, 1989	Substantially Equivalent	PARKELL
K891455	DENTIN PRIMER	May 18, 1989	Substantially Equivalent	DENTSPLY INTL.
K884533	SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM	Apr 12, 1989	Substantially Equivalent	BLOCK DRUG COMPANY, INC.
K885010	TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING	Feb 13, 1989	Substantially Equivalent	COE LABORATORIES, INC.
K884918	PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER	Feb 13, 1989	Substantially Equivalent	PARKELL
K884752	KETAC-GLAZE	Jan 19, 1989	Substantially Equivalent	ESPE GMBH (US)
K884137	MIRAGE BOND	Dec 07, 1988	Substantially Equivalent	CHAMELEON DENTAL PRODUCTS, INC.
K880684	XR PRIMER	May 11, 1988	Substantially Equivalent	KERR CORPORATION (DANBURY)
K874074	TEMPORARY DISCLOSING SOLUTION	Dec 29, 1987	Substantially Equivalent	DENTSPLY INTL.
K872959	CLEARFIL PHOTO BOND	Nov 20, 1987	Substantially Equivalent	KURARAY CO.
K871636	CLEARFIL PORCELAIN BOND	Jul 02, 1987	Substantially Equivalent	KURARAY CO.
K863522	MODIFIED SELF-CURE BONDING AGENT	Sep 19, 1986	Substantially Equivalent	DENTSPLY INTL.
K862829	PANAGRAF	Sep 19, 1986	Substantially Equivalent	PANADENT INTERNATIONAL, INC.
K860971	DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER)	Mar 25, 1986	Substantially Equivalent	DEN-MAT CORP.
K860346	KERR PORCELITE	Mar 25, 1986	Substantially Equivalent	KERR CORPORATION (DANBURY)
K852660	ETCH AND BOND	Jul 25, 1985	Substantially Equivalent	DENTSPLY INTL.
K851056	OPAQUER/BONDING AGENT	Apr 22, 1985	Substantially Equivalent	DENTSPLY INTL.
K843025	COMMAND ENAMEL-DENT DENTAL ADHESIVE	Oct 25, 1984	Substantially Equivalent	KERR CORPORATION (DANBURY)
K843023	KERR PORCELAIN REPAIR PRIMER	Oct 25, 1984	Substantially Equivalent	KERR CORPORATION (DANBURY)
K842078	JOHNSON & JOHNSON FLAVORED ETCHING GEL	Jul 12, 1984	Substantially Equivalent	JOHNSON & JOHNSON PROFESSIONALS, INC.
K840726	RESTODENT DENTIN BONDING AGENT	Jun 27, 1984	Substantially Equivalent	LEE PHARMACEUTICALS
K841458	NUMBER 20 R/L SYSTEM	May 22, 1984	Substantially Equivalent	PENTRON CORP.
K841457	NUMBER 21 R/R SYSTEM	May 22, 1984	Substantially Equivalent	PENTRON CORP.
K833718	ETCHING GEL	Dec 29, 1983	Substantially Equivalent	JOHNSON & JOHNSON PROFESSIONALS, INC.
K833473	DENTIN BONDING AGENT	Dec 27, 1983	Substantially Equivalent	JOHNSON & JOHNSON PROFESSIONALS, INC.
K830387	MICRODAPT DENTAL RESTORATIVE BONDING	Mar 17, 1983	Substantially Equivalent	JOHNSON & JOHNSON PROFESSIONALS, INC.
K822451	AURAFILL* DENTAL RESTORATIVE BONDING AG.	Sep 07, 1982	Substantially Equivalent	JOHNSON & JOHNSON PROFESSIONALS, INC.
K813180	SCOTCHBOND DENTAL ADHESIVE	Jan 12, 1982	Substantially Equivalent	3M COMPANY
K812117	PERMAGUM ADHESIVE	Aug 31, 1981	Substantially Equivalent	ESPE-PREMIER SALES CO.
K812116	PERMAGUM	Aug 31, 1981	Substantially Equivalent	ESPE-PREMIER SALES CO.
K810407	HYDROXYLATE ENAMEL BOND SYSTEM	Mar 17, 1981	Substantially Equivalent	WALLACE A. ERICKSON & CO.
K810265	VISIO-BAND	Feb 23, 1981	Substantially Equivalent	ESPE-PREMIER SALES CO.
K802681	HELIOBOND	Nov 24, 1980	Substantially Equivalent	VIVADENT (USA), INC.
K802333	INSTANT BRIDGE	Nov 12, 1980	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K801216	DEN-MAT DENTIN BONDING AGENT	May 28, 1980	Substantially Equivalent	DEN-MAT CORP.
K801093	PRISMA-BOND	May 20, 1980	Substantially Equivalent	DENTSPLY INTL.
K800390	ANT. & POST. RESTORATIVE POWDER LIQ.	Apr 10, 1980	Substantially Equivalent	AMERICAN DENTAL RESEARCH
K800389	ANTERIOR & POST. RESTORATIVE PASTE SYS.	Apr 10, 1980	Substantially Equivalent	AMERICAN DENTAL RESEARCH
K790833	VISIO-BOND	Apr 30, 1979	Unknown	ESPE GMBH (US)
K782080	VENEER SYSTEM, MOSTIQUE LAMINATE	Jan 26, 1979	Substantially Equivalent	CAULK CO., DIV. DENTSPLY
K771328	UVIOBOND	Aug 03, 1977	Substantially Equivalent	ESPE GMBH (US)
K771326	NIMETIC BONDING MATERIAL	Aug 02, 1977	Substantially Equivalent	ESPE GMBH (US)
K771325	NIMETIC ETCHING GEL	Aug 02, 1977	Substantially Equivalent	ESPE GMBH (US)
K760400	BONDING AGENT, VYTOL	Aug 23, 1976	Substantially Equivalent	L.D. CAULK CO.
K760324	BONDING AGENT, PRESTIGE	Aug 03, 1976	Substantially Equivalent	LEE PHARMACEUTICALS

FEI Numbers

This FDA classification entry is associated with 133 FEI numbers. Click on an entry to view related FDA registrations.

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1000272892: 17 registrations

1013257: 6 registrations

1032227: 93 registrations

1215305: 79 registrations

1281412: 38 registrations

1410097: 126 registrations

1413399: 3 registrations

1413475: 53 registrations

1420052: 78 registrations

1420089: 58 registrations

1450653: 53 registrations

1718476: 36 registrations

1718912: 102 registrations

1815540: 28 registrations

2014676: 28 registrations

2018957: 98 registrations

2020467: 51 registrations

2020493: 56 registrations

2022039: 55 registrations

2023950: 67 registrations

2024312: 150 registrations

2027375: 22 registrations

2081055: 12 registrations

2110898: 169 registrations

2126683: 48 registrations

2183301: 191 registrations

2244812: 19 registrations

2411797: 47 registrations

2429849: 35 registrations

2433629: 27 registrations

2511556: 113 registrations

2515379: 99 registrations

2523320: 75 registrations

2916735: 29 registrations

3000209941: 62 registrations

3000219976: 31 registrations

3000368601: 106 registrations

3000719964: 98 registrations

3001027751: 15 registrations

3001746544: 72 registrations

3002088145: 69 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

3002807166: 35 registrations

3002807420: 38 registrations

3002808149: 74 registrations

3002808289: 76 registrations

3002808636: 93 registrations

3002811563: 20 registrations

3002838732: 1 registration

3003120666: 37 registrations

3003258642: 21 registrations

3003449480: 25 registrations

3003621174: 21 registrations

3003667632: 34 registrations

3004140838: 37 registrations

3004150030: 41 registrations

3004425647: 57 registrations

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