Product Code: DYH FDA class 2 21 CFR 872.3750

Adhesive, Bracket And Tooth Conditioner, Resin

Dental

The Resin Bracket and Tooth Conditioner Adhesive is a dental device used to bond orthodontic brackets or other dental restorations to tooth surfaces, with a conditioning agent that prepares the enamel or dentin to improve adhesion. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DYH and the applicable regulation is 21 CFR 872.3750, under the Dental medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

192

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: DYH
Device Class: FDA class 2
Regulation Number: 872.3750
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 192 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250015	Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive	Jan 03, 2025	Substantially Equivalent	Ormco Corporation
K242537	BracePaste Fluoride Sealant	Aug 27, 2024	Substantially Equivalent	American Orthodontics Corp.
K234043	3M Transbond Orthodontic Adhesive	Dec 22, 2023	Substantially Equivalent	3M Unitek Orthodontic Products
K231817	AlignerFlow LC	Dec 01, 2023	Substantially Equivalent	VOCO GmbH
K214054	TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520	Oct 14, 2022	Substantially Equivalent	TP Orthodontics, Inc.
K210115	FiteBac CC OrthoSeal	Jul 29, 2021	Substantially Equivalent	Largent Health, LLC
K202276	BracePaste Band and Build LC	Aug 14, 2020	Substantially Equivalent	American Orthodontics
K192682	Orthocem, Ortho Bite	Aug 14, 2020	Substantially Equivalent	Dentscare Ltda
K193388	GlassLok Kits, GlassLok Powder, GlassLok Liquid	Apr 27, 2020	Substantially Equivalent	Reliance Orthodontic Products Inc.
K183147	BrackFix	Mar 01, 2019	Substantially Equivalent	VOCO GmbH
K173020	OBA-MCP, Orthodontic Bracket Adhesive with MCP	Jan 17, 2018	Substantially Equivalent	Pulpdent Corporation
K160782	BracePaste Adhesive	Oct 14, 2016	Substantially Equivalent	American Orthodontics
K161684	Quantum LB	Oct 06, 2016	Substantially Equivalent	Reliance Orthodontic Products Inc.
K150128	GC Ortho Connect, GC Ortho Etching Gel	Jul 16, 2015	Substantially Equivalent	GC Orthodontics America Inc.
K143667	GC KommonBase	May 07, 2015	Substantially Equivalent	GC Orthodontics America Inc.
K142886	DMRC Self-Cure Bracket Adhesive One Step and Primer	Mar 18, 2015	Substantially Equivalent	DANVILLE MATERIALS, LLC.
K142881	DMRC Dual Cure Orthodontic Band Cement	Feb 13, 2015	Substantially Equivalent	DANVILLE MATERIALS, LLC.
K142880	DMRC Light Cure Orthodontic Adhesive System	Feb 04, 2015	Substantially Equivalent	Daville Materials LLC
K123348	CLEAR ALIGNER ADHESIVE	Feb 28, 2013	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K120619	ORTHODONTIC FLOWABLE BRACKET ADHESIVE	May 21, 2012	Substantially Equivalent	NOVOCOL, INC.
K113401	ORTHO-1(NOT FINALIZED)	Feb 07, 2012	Substantially Equivalent	BISCO, INC.
K113197	APC FLASH-FREE ADHESIVE	Feb 02, 2012	Substantially Equivalent	3M UNITEK CORPORATION
K111814	PADLOCK	Sep 14, 2011	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K111696	OPAL BAND CEMENT	Sep 07, 2011	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K101951	LIGHT CURE RETAINER	Oct 26, 2010	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K100536	TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE	Jul 27, 2010	Substantially Equivalent	3M UNITEK
K100301	OPAL BOND FLOW	Apr 29, 2010	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K094006	OPAL BOND MV	Mar 23, 2010	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K093221	PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II	Oct 30, 2009	Substantially Equivalent	DENTSPLY INTL., INC.
K090355	OPAL SEAL	Apr 29, 2009	Substantially Equivalent	ULTRADENT PRODUCTS, INC.
K083051	FLOWTAIN & FLOWTAIN LV	Feb 20, 2009	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K080445	LION SE ONE STEP ORTHODONTIC ADHESIVE	Jul 16, 2008	Substantially Equivalent	CLASSONE ORTHODONTICS, INC.
K080724	GC OPB-100	Jun 11, 2008	Substantially Equivalent	GC AMERICA, INC.
K081291	PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION	May 22, 2008	Substantially Equivalent	DENTSPLY INTERNTIONAL
K073697	TRANSBOND SUPREME ADHESIVE	Feb 15, 2008	Substantially Equivalent	3M UNITEK
K073588	GC MODELS OPA-100 AND JC-50	Feb 15, 2008	Substantially Equivalent	GC AMERICA, INC.
K072978	TENDER ORTHO BOND-ENA BOND-ENA ETCH	Jan 17, 2008	Substantially Equivalent	MICERIUM S.P.A.
K072830	RM BOND, MODEL J032	Dec 04, 2007	Substantially Equivalent	PENTRON CLINICAL TECHNOLOGIES
K071590	THERMA-CURE	Jul 31, 2007	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K061252	PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM	Feb 12, 2007	Substantially Equivalent	PRIMUS CONSULTING
K061481	GRENGLOO	Jul 06, 2006	Substantially Equivalent	ORMCO CORP.
K053379	RELI-ON ONE STEP, ORTHODONTIC ADHESIVE	Jan 25, 2006	Substantially Equivalent	CLASSONE ORTHODONTICS, INC.
K050750	LC BRACKET ADHESIVE SYSTEM	Apr 06, 2005	Substantially Equivalent	DENTSPLY INTL.
K042422	D3 CHROMA	Nov 15, 2004	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K040375	IDEAL 1 ORTHODONTIC BAND CEMENT	Apr 02, 2004	Substantially Equivalent	DENTSPLY INTL.
K040548	AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE	Mar 19, 2004	Substantially Equivalent	HARRY J. BOSWORTH CO.
K040547	AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE	Mar 19, 2004	Substantially Equivalent	HARRY J. BOSWORTH CO.
K033703	IDEAL 1 ORTHODONTIC BRACKET ADHESIVE	Feb 06, 2004	Substantially Equivalent	DENTSPLY INTL.
K033551	EVOLVE	Dec 16, 2003	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K030644	CONTEC DUO, CONTEC LC, CONTEC LCR	Nov 21, 2003	Substantially Equivalent	DENTAURUM
K032195	DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT	Oct 07, 2003	Substantially Equivalent	DENTAURUM
K032407	OPTIBAND LC	Oct 06, 2003	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K032042	ENVISION	Sep 29, 2003	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K030980	DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE	Aug 25, 2003	Substantially Equivalent	DENTAURUM
K030977	DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE	Aug 25, 2003	Substantially Equivalent	DENTAURUM
K031420	S & C -BRACKET ADHESIVES	Aug 20, 2003	Substantially Equivalent	S & C POLYMER GMBH
K030036	TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT	Mar 12, 2003	Substantially Equivalent	PULPDENT CORPORATION
K022224	COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM	Sep 18, 2002	Substantially Equivalent	COLTENE AG
K020648	GRIDLOCK 195 ADHESIVE	May 01, 2002	Substantially Equivalent	ALLODEX SYSTEMS
K020502	SOLO ORTHO 3	May 01, 2002	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K020578	GC FUJI ORTHO BAND PASTE PAK	Apr 26, 2002	Substantially Equivalent	GC AMERICA, INC.
K020394	APC PLUS ADHESIVE	Apr 12, 2002	Substantially Equivalent	3M UNITEK
K014138	PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT	Mar 14, 2002	Substantially Equivalent	PULPDENT CORP.
K014133	PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE	Mar 14, 2002	Substantially Equivalent	PULPDENT CORP.
K020115	PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM	Feb 28, 2002	Substantially Equivalent	PULPDENT CORP.
K014142	UNITE BONDING ADHESIVE	Feb 28, 2002	Substantially Equivalent	3M UNITEK
K014059	PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE	Feb 27, 2002	Substantially Equivalent	PULPDENT CORP.
K012673	PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM	Oct 24, 2001	Substantially Equivalent	PRIME DENTAL MANUFACTURING, INC.
K012032	FIRST SPEP	Sep 17, 2001	Substantially Equivalent	BISCO, INC.
K010544	VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE	Aug 10, 2001	Substantially Equivalent	APEX DENTAL MATERIALS, INC.
K011521	ORTHO VLC; ORTHO VLC CAPSULE	Aug 01, 2001	Substantially Equivalent	FIRST SCIENTIFIC LIMITED
K001881	IMPROVED ENLIGHT LV	Aug 22, 2000	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K001446	LIGHT-CURED ORTHODONTIC BAND CEMENT	Jul 21, 2000	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K001048	LIGHT BOND (QUICK CURE)	Apr 27, 2000	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K994309	SOLO ORTHO 2	Mar 17, 2000	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K990743	SOLO ORTHO	Jun 04, 1999	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K981036	SMARTBOND	Apr 05, 1999	Substantially Equivalent	GAC INTL., INC.
K990252	SOLO PLUS ORTHO	Feb 25, 1999	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K984362	ENLIGHT LV	Jan 21, 1999	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K984217	ENLIGHT-2	Jan 20, 1999	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K981461	GC FUJI ORTHO LC	Jun 25, 1998	Substantially Equivalent	GC AMERICA, INC.
K972890	ENLIGHT (TENTATIVE NAME)	Sep 16, 1997	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K962946	ORTHO-ONE	Sep 03, 1996	Substantially Equivalent	BISCO, INC.
K961417	GC FUJI ORTHO	May 24, 1996	Substantially Equivalent	GC AMERICA, INC.
K955329	RESILIENCE M5 PROTECTION PLUS	Mar 28, 1996	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K954374	AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM	Oct 19, 1995	Substantially Equivalent	AMERICAN DENTAL PRODUCTS, INC.
K954373	AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE	Oct 19, 1995	Substantially Equivalent	AMERICAN DENTAL PRODUCTS, INC.
K954372	AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE	Oct 17, 1995	Substantially Equivalent	AMERICAN DENTAL PRODUCTS, INC.
K954333	AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM	Oct 12, 1995	Substantially Equivalent	AMERICAN DENTAL PRODUCTS, INC.
K954244	AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM W/FLUORIDE	Oct 12, 1995	Substantially Equivalent	AMERICAN DENTAL PRODUCTS, INC.
K952856	LIGHT-CURE PC	Sep 12, 1995	Substantially Equivalent	MIDWEST ORTHODONTIC MFG.
K952855	PC-LOCK	Sep 08, 1995	Substantially Equivalent	MIDWEST ORTHODONTIC MFG.
K952858	LIGHT-CURE	Sep 05, 1995	Substantially Equivalent	MIDWEST ORTHODONTIC MFG.
K952857	PRO-LOCK	Sep 05, 1995	Substantially Equivalent	MIDWEST ORTHODONTIC MFG.
K953217	PULPDENT TOUCHDOWN	Aug 25, 1995	Substantially Equivalent	PULPDENT CORP.
K952854	PULPDENT GLASS IONOMER CEMENTS	Jul 14, 1995	Substantially Equivalent	PULPDENT CORP.
K952643	RIGHT-ON ADHESIVE BOUDING SYSTEM	Jul 11, 1995	Substantially Equivalent	TP ORTHODONTICS, INC.
K951381	VILA	Apr 27, 1995	Substantially Equivalent	HEALTH-DENT INTL., INC.
K951380	VILA PC	Apr 27, 1995	Substantially Equivalent	HEALTH-DENT INTL., INC.
K951235	GIROC	Apr 20, 1995	Substantially Equivalent	HEALTH-DENT INTL., INC.
K951236	PRO-LOCK	Apr 18, 1995	Substantially Equivalent	HEALTH-DENT INTL., INC.
K950556	FUJI ORTHO LC	Mar 08, 1995	Substantially Equivalent	GC AMERICA, INC.
K950514	TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT	Mar 07, 1995	Substantially Equivalent	3M UNITEK
K950512	AMERICAN DENTAL PRODUCTS (ADP), FLUORIDE RELEASING GLASS IONOMER BAND CEMENT	Mar 07, 1995	Substantially Equivalent	AMERICAN DENTAL PRODUCTS, INC.
K946255	THERMASET	Jan 27, 1995	Substantially Equivalent	ORMCO CORP.
K942742	ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV	Aug 29, 1994	Substantially Equivalent	WALLACE A. ERICKSON & CO.
K942727	ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE	Aug 23, 1994	Substantially Equivalent	WALLACE A. ERICKSON & CO.
K935625	ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE	Aug 10, 1994	Substantially Equivalent	WALLACE A. ERICKSON & CO.
K941015	ORMCO SYSTEM 1+ (TM)	Mar 31, 1994	Substantially Equivalent	ORMCO CORP.
K940845	SYSTEM 1	Mar 31, 1994	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K935714	CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE	Jan 21, 1994	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K925359	RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS	Jul 08, 1993	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K930614	ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYST	Jun 17, 1993	Substantially Equivalent	WALLACE A. ERICKSON & CO.
K921283	ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN	Dec 23, 1992	Substantially Equivalent	JENERIC/PENTRON, INC.
K921044	ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND	Nov 09, 1992	Substantially Equivalent	WALLACE A. ERICKSON & CO.
K923399	CHALLENGE II - PASTE ADHESIVE	Oct 27, 1992	Substantially Equivalent	ORMCO CORP.
K921245	THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II	May 05, 1992	Substantially Equivalent	ORMCO CORP.
K921385	IMPROVED SEQUENCE LIGHT CURE ADHESIVE	Apr 21, 1992	Substantially Equivalent	ORMCO CORP.
K920781	FLASH BOND	Apr 21, 1992	Substantially Equivalent	ADVANCED ORTHODONTICS SYSTEMS, INC.
K920534	PORCELAIN PRIMER	Mar 26, 1992	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K914317	ORTHODONTIC BRACKET ADHESIVE RESIN MATERIAL	Mar 26, 1992	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K914727	SEQUENCE LIGHT CURE ADHESIVE	Jan 17, 1992	Substantially Equivalent	ORMCO CORP.
K913854	ORTHO LIGHT CURE	Jan 14, 1992	Substantially Equivalent	ORTHO SOURCE
K911286	PULPDENT ORTHODONTIC BRACKET ADHESIVE	Jul 05, 1991	Substantially Equivalent	PULPDENT CORP.
K911271	ADHESIVE PRECOATED BRACKETS	May 29, 1991	Substantially Equivalent	UNITEK CORP.
K904090	ORTHODONTIC BONDING ADHESIVE CONTROL	Apr 29, 1991	Substantially Equivalent	LANCER ORTHODONTICS, INC.
K910803	ENAMEL ETCHING GEL	Mar 15, 1991	Substantially Equivalent	GRESCO PRODUCTS, INC.
K895523	PHASE II ORTHODONTIC ADHESIVE	Dec 08, 1989	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K895522	LIGHT BOND PASTE W/FLUORIDE	Dec 07, 1989	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K895521	RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE)	Dec 07, 1989	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K895163	FORCE II	Oct 27, 1989	Substantially Equivalent	AMERICAN ORTHODONTICS
K894639	SKYROCK AND LIGHT SUPERBOND	Oct 20, 1989	Substantially Equivalent	DENT ZAR, INC.
K894565	LIGHT BOND SEALANT WITH FLUORIDE	Oct 13, 1989	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K894566	MAXIMUM CURE SEALANT WITH FLUORIDE	Sep 19, 1989	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K893396	AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM	Jun 23, 1989	Substantially Equivalent	AMERICAN ORTHODONTICS
K893255	SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE	Jun 21, 1989	Substantially Equivalent	AMERICAN ORTHODONTICS
K893037	NO-MIX 30 ORTHODONTIC BONDING SYSTEMS	Jun 12, 1989	Substantially Equivalent	AMERICAN ORTHODONTICS
K891464	RESILIENCE C2, RESILIENCE L3 & RESILIENCE P4	May 18, 1989	Substantially Equivalent	CONFI-DENTAL PRODUCTS CO.
K890834	NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC	May 01, 1989	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K890740	FRS LITE FLUORIDE RELEASING SEALANT	Apr 25, 1989	Substantially Equivalent	ORMCO CORP.
K884575	MAXIBOND	Jan 03, 1989	Substantially Equivalent	ORTHO SOURCE
K883465	ORTHO-SEAL	Oct 12, 1988	Substantially Equivalent	BISCO, INC.
K880562	ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT	Aug 19, 1988	Substantially Equivalent for Some Indications	MACROCHEM CORP.
K880793	LIGHT BOND	Jun 13, 1988	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K880791	MAXIMUM CURE SEALANT	Jun 13, 1988	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K880766	RELIANCE METAL PRIMER	Apr 25, 1988	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K880792	PLASTIC PRIMER	Apr 18, 1988	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K880790	PORCELAIN PRIMER	Apr 18, 1988	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K880393	TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE	Mar 31, 1988	Substantially Equivalent	UNITEK CORP.
K874228	BOND FAST NO MIX ADHESIVE	Mar 18, 1988	Substantially Equivalent	ADVANCED ORTHODONTICS SYSTEMS, INC.
K875142	PHASE II	Feb 29, 1988	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K875144	EXCEL FAST SET	Feb 26, 1988	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K875143	RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE)	Feb 26, 1988	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K875141	EXCEL REGULAR SET	Feb 26, 1988	Substantially Equivalent	RELIANCE ORTHODONTIC PRODUCTS, INC.
K871591	ORMCO GEL-ETCH	May 18, 1987	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K863709	CHALLENGE ORTHODONTIC BONDING ADHESIVE	Jan 21, 1987	Substantially Equivalent	ORMCO CORP.
K864008	ACCLAIM* BRACKET ADHESIVE	Oct 24, 1986	Substantially Equivalent	JOHNSON & JOHNSON PROFESSIONALS, INC.
K861118	ORTHOJOIN, ORTHODONTIC ADHESIVE	May 02, 1986	Substantially Equivalent	ORTHO SOURCE
K861258	PERMABAND (ORTHODONTIC ADHESIVE)	Apr 17, 1986	Substantially Equivalent	ORTHO SOURCE
K860959	DEPENDABOND	Mar 25, 1986	Substantially Equivalent	ORTHO SOURCE
K844844	ESPE NIMETIC-GRIP	Feb 13, 1986	Substantially Equivalent	ESPE GMBH (US)
K854050	EXCEL BRACKET ADHESIVE	Nov 26, 1985	Substantially Equivalent	JOHNSON & JOHNSON PROFESSIONALS, INC.
K853523	VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE	Nov 07, 1985	Substantially Equivalent	DENTSPLY INTL.
K844134	CLEANSE N BOND II	Jan 04, 1985	Substantially Equivalent	LEE PHARMACEUTICALS
K844133	CLEANSE N BOND I	Jan 04, 1985	Substantially Equivalent	LEE PHARMACEUTICALS
K843527	ORTHOMITE 111 ADHESIVE	Oct 18, 1984	Substantially Equivalent	ROCKY MOUNTAIN ORTHODONTICS, INC.
K842448	BOSWORTH SUPER BOND DENTAL ADHESIVE	Sep 27, 1984	Substantially Equivalent	HARRY J. BOSWORTH CO.
K832292	SOLO-TACH	Sep 01, 1983	Substantially Equivalent	DENTSPLY INTL.
K832291	AUTO-TACH	Aug 31, 1983	Substantially Equivalent	DENTSPLY INTL.
K832112	NO-MIX 30 ORTHODONTIC BONDING SYSTEM	Aug 31, 1983	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K831495	CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO	Jul 18, 1983	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K823928	TOOTH CONDITIONER	Jan 26, 1983	Substantially Equivalent	DENTSPLY INTL.
K823409	HELIOSIT-ORTHODONTIC	Jan 21, 1983	Substantially Equivalent	VIVADENT (USA), INC.
K823851	ORTHODAPTIC* BONDING ADHESIVE	Jan 09, 1983	Substantially Equivalent	JOHNSON & JOHNSON PROFESSIONALS, INC.
K820092	SECURE-ON-TOUCH	Feb 24, 1982	Substantially Equivalent	SCI-PHARM, INC.
K812547	BEAUBON	Sep 23, 1981	Substantially Equivalent	SCI-PHARM, INC.
K810959	SECURE	Apr 21, 1981	Substantially Equivalent	SCI-PHARM, INC.
K810715	SECURE	Apr 21, 1981	Substantially Equivalent	SCI-PHARM, INC.
K810517	INSTA-BOND	Mar 24, 1981	Substantially Equivalent	LEE PHARMACEUTICALS
K810241	CRYSTAL-BOND	Feb 12, 1981	Substantially Equivalent	AMERICAN ORMCO
K810210	MAGIC-TOUCH	Feb 10, 1981	Substantially Equivalent	SCI-PHARM, INC.
K800392	BRACKET BONDING SYSTEM METAL & PLASTIC	Apr 10, 1980	Substantially Equivalent	AMERICAN DENTAL RESEARCH
K792003	1 STEP	Nov 27, 1979	Substantially Equivalent	BETTA DENTAL, INC.
K791132	SCI-PHARM ORTHODONTIC ADHESIVE	Aug 10, 1979	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K790962	SEAL & BOND DIRECT BONDING ORTHODONTIC	Jul 06, 1979	Substantially Equivalent	SCIENTIFIC PHARMACEUTICALS, INC.
K780334	ADHESIVE, BRACKET AND CONDITIONER RESIN	Mar 28, 1978	Substantially Equivalent	ROCKY MOUNTAIN ORTHODONTICS, INC.
K780028	ORTHODONTIC. PLASTIC BRACKET PRIMER	Jan 17, 1978	Substantially Equivalent	3M COMPANY
K772126	TEMP. BRIDGE, POSTERIOR 3-UNIT	Jan 03, 1978	Substantially Equivalent	LEE PHARMACEUTICALS
K771883	REPLICA ACID-ETCH	Oct 20, 1977	Substantially Equivalent	HOYT LABORATORIES
K771076	ORTHODONTIC BRACKET ADHESIVE	Jun 24, 1977	Substantially Equivalent	LEE PHARMACEUTICALS
K760378	CEMENT, RESIN DENTAL (AUTO-TACH)	Aug 23, 1976	Substantially Equivalent	L.D. CAULK CO.
K760376	CEMENT, RESIN DENTAL (SOLO-TACH)	Aug 23, 1976	Substantially Equivalent	L.D. CAULK CO.

FEI Numbers

This FDA classification entry is associated with 64 FEI numbers. Click on an entry to view related FDA registrations.

1000118628: 50 registrations

1000272892: 17 registrations

1215305: 79 registrations

1410097: 126 registrations

1413475: 53 registrations

1420052: 78 registrations

1420089: 58 registrations

1450653: 53 registrations

1718476: 36 registrations

1718912: 102 registrations

1721647: 24 registrations

1815540: 28 registrations

2018957: 98 registrations

2020467: 51 registrations

2020493: 56 registrations

2022039: 55 registrations

2023950: 67 registrations

2024312: 150 registrations

2027375: 22 registrations

2110898: 169 registrations

2126683: 48 registrations

3002718942: 129 registrations

3002807050: 47 registrations

3002807052: 50 registrations

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