Prosthetic devices · 21 CFR 872 Subpart D

Resin Bracket and Tooth Conditioner Adhesive

FDA device type “Adhesive, Bracket And Tooth Conditioner, Resin”.

FDA codeDYHClass221 CFR872.3750Pathway510(k)
Companies listing it
5426 makers
Brands and models
199
510(k) clearances
1958 in five years
FDA name
Adhesive, Bracket And Tooth Conditioner, Resin
1976: 21977: 21978: 31979: 31980: 11981: 61982: 11983: 71984: 21985: 41986: 51987: 21988: 131989: 141991: 41992: 101993: 21994: 61995: 201996: 31997: 11998: 11999: 52000: 42001: 42002: 102003: 92004: 52005: 12006: 22007: 32008: 62009: 32010: 42011: 22012: 32013: 12015: 52016: 22018: 12019: 12020: 32021: 12022: 12023: 22024: 12025: 12026: 319801990200020102020

510(k) clearances per year, 1976–2026

Companies that list DYH

54 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Spident Co., Ltd.South KoreaMakerOrthoFit · OrthoFit Aligner222026
Voco GmbHGermanyMakerAlignerFlow LC · BrackFix1172026
GC America Inc.United StatesMakerFuji Ortho LC · G-aenial Injectable Pro · G-aenial Injectable Pro Bulk · G-aenial Universal Injectable II · +181372026
Zest Anchors, LLCUnited StatesMaker—262026
Sybron Dental SpecialtiesUnited StatesMaker—2032026
Ultradent Products, Inc.United StatesMakerOpal Band Cement · Opal Bond · Opal Bond Flow · Opal Bond MV · +3952026
American OrthodonticsUnited StatesMakerBracePaste · Bracepaste - Color Change · BracePaste Band And Build LC · BracePaste Fluoride Sealant · +7442026
Premier Dental Products CompanyUnited StatesMakerMultiMatch Flow Chameleon AntiMicrobial Composite282026
Bisco, Inc.United StatesMakerLIQUID ETCHANT · ORTHO-ONE882025
Dentscare LtdaBrazilMakerOrtho Bite · Orthocem102024
Den-Mat Holdings, LLCUnited StatesMakerCerinate Prime · Etch 'N' Seal · Etchant · Porcelain Conditioner · +182026
Tp Orthodontics, Inc.United StatesMakerEnamel Conditioner52022
Pulpdent CorporationUnited StatesMakerOC Orthodontic Bracket Adhesive · ORTHO-CHOICE BAND-RITE · Ortho-Choice OBA1072021
Scientific PharmaceuticalsUnited StatesMakerBand Secure · CuRay Eclipse · Cure-On-Touch · No-Mix 30 Orthodontic Bond System · +3732020
Reliance Orthodontic Products, Inc.United StatesMakerAqua Bond · Assure · Bonding Resin · Clear Aligner Adhesive · +24322021
S & C Polymer GmbHGermanyMaker—202009
Prime Dental Manufacturing, Inc.United StatesMakerPrime-Dent Dual Cure Glass Ionomer Band Cement · Prime-Dent Light Cure Glass Ionomer Band Cement · Prime-Dent Megaset · Prime-Dent One Step Orthodontic Adhesive · +192012
Micerium S.P.A.ItalyMakerENA BOND · ENA ETCH · Ena Seal · TENDER ORTHO BOND62011
Dental Technologies, Inc.United StatesMakerAdhesive, Bracket&Conditioner Resin · Alpha-Dent Light Cure Bracket Adhesive · Alpha-Dent Paste & Paste Bracket Adhesive22013
Gestenco International ABSwedenMaker—12005
Dentaurum GmbH & Co. KGGermanyMakerConTec · ConTec LC · ConTec LCR · ConTec SE · +2——
B.J.M. Laboratories LtdIsraelMakerHIGH-Q-BOND · HIGH-Q-BOND BAND CEMENT · HIGH-Q-BOND BRACKET ADHESIVE · HIGH-Q-BOND BRACKET comprising PRIMER, LIGHT CURE ADHESIVE, ETCHANT · +14——
Solventum US LLCUnited StatesMakerTransbond LR · Transbond Supreme Adhesive, · Transbond Supreme Low Viscosity Adh · Transbond Supreme LV Adhesive, · +3——
medmix Deutschland GmbHGermanyMaker———
ConamcoUnited StatesMakerCrushed Quartz——
MANI Medical Germany GmbHGermanyMaker———
Young Innovations IncUnited StatesContract manufacturerAdhere" Enamel Etch Conditioner · Adhere" Light Cure Adhesive 5g Syringe · Adhere" Light Cure Adhesive Kit · Adhere" Light Cure Adhesive Primer · +7232025
Cosmedent, Inc.United StatesRepacker / relabelerCompositeEtch272024
Dent Zar, Inc.United StatesRepacker / relabelerSkyrock121996
GC OrthodonticsUnited StatesManufacturerGC KommonBase · GC Ortho Connect & GC Ortho Etching Gel22015
Synca MarketingCanadaForeign exporterTender Ortho Bond-Ena Bond-Ena Etch12010
Rmo, Inc.United StatesManufacturerAdhesive Orthodontic Bracket and Tooth Conditioner Resin - TruLock11990
Five Star Orthodontic Laboratory & Supply, Inc.United StatesContract manufacturerFuji Ortho LC · Fuji Ortho SC · Light Bond · liquid etch · +6——
Jersey Dental SuppliesUnited StatesRepacker / relabelerADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN · GC FUJI ORTHO BAND PASTE REFILL——
TitanLinks Logistics LLCUnited StatesRepacker / relabelerAdhesive · Adhesive, Bracket · TransBond——
Jmu Dental, Inc.United StatesRepacker / relabelerAdhesive, Resin, Composite——
Ortho Pro Dent LLCUnited StatesRepacker / relabeleracid etch and accessories · Adhesive bonding system · Devon Bond - light cure · Devondent orthodontic Adhesive - light cure · +8——
Soher Med LimitedHong Kong SAR ChinaForeign exporterAdhesive · Adhesive, Bracket · Unitek——
Samtrade Supplies Inc.CanadaForeign exporterFuji Ortho kit · Transbond——
International Orthodontics Services. PCUnited StatesRepacker / relabelerBand-Guard——
Csy International LLCUnited StatesRepacker / relabelerJ&J ORTHODONTICS——
Aditek do Brasil SABrazilContract manufacturer———
First Dental Supplies LLCUnited StatesRepacker / relabelerADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN——
Xplora USA LLCUnited StatesManufacturerSix Month Smiles——
Specialty Appliances, LLCUnited StatesManufacturer———
US Orthodontic ProductsUnited StatesRepacker / relabelerAdhesive Resin Bracket and Tooth Conditioner · Tooth Shade Resin Material——
Viarden Lab LLCUnited StatesManufacturer for exportION GLASS ORTHO, ORTHO LUX——
Dentonics IncUnited StatesRepacker / relabelerMaster-Dent——
Sanicure BVNetherlandsForeign exporter———
O&S Dental IncUnited StatesManufacturer for exportOrthoVita Etchant Liquid · OrthoVita Light Cure Band Cement · OrthoVita Light Cure Orthodontic Adhesive · OrthoVita Light Cure Primer——
3D Dental Designs and Development LLCUnited StatesContract manufacturer———
Frontier Dental Supply IncCanadaForeign exporter———
Mainline Medical Dental SupplyCanadaForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
13 Oct 2026K262433OrthoFit Aligner (OrthoFit Aligner A2)Spident Co., Ltd.
2 Jul 2026K261129OrthoFitSpident Co., Ltd.
3 Jun 2026K261840BracePaste Prime PlusAmerican Orthodontics
3 Jan 2025K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveSybron Dental Specialties
27 Aug 2024K242537BracePaste Fluoride SealantAmerican Orthodontics
22 Dec 2023K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic Products
1 Dec 2023K231817AlignerFlow LCVoco GmbH
14 Oct 2022K214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520Tp Orthodontics, Inc.
29 Jul 2021K210115FiteBac CC OrthoSealLargent Health, LLC
14 Aug 2020K202276BracePaste Band and Build LCAmerican Orthodontics
14 Aug 2020K192682Orthocem, Ortho BiteDentscare Ltda
27 Apr 2020K193388GlassLok Kits, GlassLok Powder, GlassLok LiquidReliance Orthodontic Products, Inc.
1 Mar 2019K183147BrackFixVoco GmbH
17 Jan 2018K173020OBA-MCP, Orthodontic Bracket Adhesive with MCPPulpdent Corporation
14 Oct 2016K160782BracePaste AdhesiveAmerican Orthodontics
6 Oct 2016K161684Quantum LBReliance Orthodontic Products, Inc.
16 Jul 2015K150128GC Ortho Connect, GC Ortho Etching GelGC Orthodontics
7 May 2015K143667GC KommonBaseGC Orthodontics
18 Mar 2015K142886DMRC Self-Cure Bracket Adhesive One Step and PrimerDanville Materials, LLC
13 Feb 2015K142881DMRC Dual Cure Orthodontic Band CementDanville Materials, LLC
4 Feb 2015K142880DMRC Light Cure Orthodontic Adhesive SystemDaville Materials, LLC
28 Feb 2013K123348CLEAR ALIGNER ADHESIVEReliance Orthodontic Products, Inc.
21 May 2012K120619ORTHODONTIC FLOWABLE BRACKET ADHESIVENovocol, Inc.
7 Feb 2012K113401ORTHO-1(NOT FINALIZED)Bisco, Inc.
2 Feb 2012K113197APC FLASH-FREE ADHESIVE3M Unitek Corporation
14 Sep 2011K111814PADLOCKReliance Orthodontic Products, Inc.
7 Sep 2011K111696OPAL BAND CEMENTUltradent Products, Inc.
26 Oct 2010K101951LIGHT CURE RETAINERReliance Orthodontic Products, Inc.
27 Jul 2010K100536TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE3M Unitek Corporation
29 Apr 2010K100301OPAL BOND FLOWUltradent Products, Inc.
23 Mar 2010K094006OPAL BOND MVUltradent Products, Inc.
30 Oct 2009K093221PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION IIDentsply Intl., Inc.
29 Apr 2009K090355OPAL SEALUltradent Products, Inc.
20 Feb 2009K083051FLOWTAIN & FLOWTAIN LVReliance Orthodontic Products, Inc.
16 Jul 2008K080445LION SE ONE STEP ORTHODONTIC ADHESIVEClassone Orthodontics, Inc.
11 Jun 2008K080724GC OPB-100GC America Inc.
22 May 2008K081291PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSIONDentsply Interntional
15 Feb 2008K073697TRANSBOND SUPREME ADHESIVE3M Unitek Corporation
15 Feb 2008K073588GC MODELS OPA-100 AND JC-50GC America Inc.
17 Jan 2008K072978TENDER ORTHO BOND-ENA BOND-ENA ETCHMicerium S.P.A.
4 Dec 2007K072830RM BOND, MODEL J032Pentron Clinical Technologies
31 Jul 2007K071590THERMA-CUREReliance Orthodontic Products, Inc.
12 Feb 2007K061252PRE-CEMENTED ORTHODONTIC BRACKET SYSTEMPrimus Consulting
6 Jul 2006K061481GRENGLOOSybron Dental Specialties
25 Jan 2006K053379RELI-ON ONE STEP, ORTHODONTIC ADHESIVEClassone Orthodontics, Inc.
6 Apr 2005K050750LC BRACKET ADHESIVE SYSTEMDentsply Intl., Inc.
15 Nov 2004K042422D3 CHROMASybron Dental Specialties
2 Apr 2004K040375IDEAL 1 ORTHODONTIC BAND CEMENTDentsply Intl., Inc.
19 Mar 2004K040548AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVEHarry J. Bosworth Co.
19 Mar 2004K040547AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVEHarry J. Bosworth Co.
6 Feb 2004K033703IDEAL 1 ORTHODONTIC BRACKET ADHESIVEDentsply Intl., Inc.
16 Dec 2003K033551EVOLVEReliance Orthodontic Products, Inc.
21 Nov 2003K030644CONTEC DUO, CONTEC LC, CONTEC LCRDentaurum
7 Oct 2003K032195DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENTDentaurum
6 Oct 2003K032407OPTIBAND LCSybron Dental Specialties
29 Sep 2003K032042ENVISIONSybron Dental Specialties
25 Aug 2003K030980DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVEDentaurum
25 Aug 2003K030977DENTAURUM MIX TWO-PASTE BRACKET ADHESIVEDentaurum
20 Aug 2003K031420S & C -BRACKET ADHESIVESS & C Polymer GmbH
12 Mar 2003K030036TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENTPulpdent Corporation
18 Sep 2002K022224COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEMColtene AG
1 May 2002K020648GRIDLOCK 195 ADHESIVEAllodex Systems
1 May 2002K020502SOLO ORTHO 3Sybron Dental Specialties
26 Apr 2002K020578GC FUJI ORTHO BAND PASTE PAKGC America Inc.
12 Apr 2002K020394APC PLUS ADHESIVE3M Unitek Corporation
14 Mar 2002K014138PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENTPulpdent Corporation
14 Mar 2002K014133PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVEPulpdent Corporation
28 Feb 2002K020115PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEMPulpdent Corporation
28 Feb 2002K014142UNITE BONDING ADHESIVE3M Unitek Corporation
27 Feb 2002K014059PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVEPulpdent Corporation
24 Oct 2001K012673PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEMPrime Dental Manufacturing, Inc.
17 Sep 2001K012032FIRST SPEPBisco, Inc.
10 Aug 2001K010544VERTEX L/C ORTHODONTIC DIRECT BONDING PASTEApex Dental Materials, Inc.
1 Aug 2001K011521ORTHO VLC; ORTHO VLC CAPSULEFirst Scientific Limited
22 Aug 2000K001881IMPROVED ENLIGHT LVSybron Dental Specialties
21 Jul 2000K001446LIGHT-CURED ORTHODONTIC BAND CEMENTScientific Pharmaceuticals
27 Apr 2000K001048LIGHT BOND (QUICK CURE)Reliance Orthodontic Products, Inc.
17 Mar 2000K994309SOLO ORTHO 2Sybron Dental Specialties
4 Jun 1999K990743SOLO ORTHOSybron Dental Specialties
5 Apr 1999K981036SMARTBONDGac Intl., Inc.
25 Feb 1999K990252SOLO PLUS ORTHOSybron Dental Specialties
21 Jan 1999K984362ENLIGHT LVSybron Dental Specialties
20 Jan 1999K984217ENLIGHT-2Sybron Dental Specialties
25 Jun 1998K981461GC FUJI ORTHO LCGC America Inc.
16 Sep 1997K972890ENLIGHT (TENTATIVE NAME)Sybron Dental Specialties
3 Sep 1996K962946ORTHO-ONEBisco, Inc.
24 May 1996K961417GC FUJI ORTHOGC America Inc.
28 Mar 1996K955329RESILIENCE M5 PROTECTION PLUSConfi-Dental Products Co.
19 Oct 1995K954374AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEMAmerican Dental Products, Inc.
19 Oct 1995K954373AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDEAmerican Dental Products, Inc.
17 Oct 1995K954372AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDEAmerican Dental Products, Inc.
12 Oct 1995K954333AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEMAmerican Dental Products, Inc.
12 Oct 1995K954244AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM W/FLUORIDEAmerican Dental Products, Inc.
12 Sep 1995K952856LIGHT-CURE PCMidwest Orthodontic Mfg.
8 Sep 1995K952855PC-LOCKMidwest Orthodontic Mfg.
5 Sep 1995K952858LIGHT-CUREMidwest Orthodontic Mfg.
5 Sep 1995K952857PRO-LOCKMidwest Orthodontic Mfg.
25 Aug 1995K953217PULPDENT TOUCHDOWNPulpdent Corporation
14 Jul 1995K952854PULPDENT GLASS IONOMER CEMENTSPulpdent Corporation
11 Jul 1995K952643RIGHT-ON ADHESIVE BOUDING SYSTEMTp Orthodontics, Inc.
27 Apr 1995K951381VILAHealth-Dent Intl., Inc.
27 Apr 1995K951380VILA PCHealth-Dent Intl., Inc.
20 Apr 1995K951235GIROCHealth-Dent Intl., Inc.
18 Apr 1995K951236PRO-LOCKHealth-Dent Intl., Inc.
8 Mar 1995K950556FUJI ORTHO LCGC America Inc.
7 Mar 1995K950514TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT3M Unitek Corporation
7 Mar 1995K950512AMERICAN DENTAL PRODUCTS (ADP), FLUORIDE RELEASING GLASS IONOMER BAND CEMENTAmerican Dental Products, Inc.
27 Jan 1995K946255THERMASETSybron Dental Specialties
29 Aug 1994K942742ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEVWallace A. Erickson & Co.
23 Aug 1994K942727ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVEWallace A. Erickson & Co.
10 Aug 1994K935625ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDEWallace A. Erickson & Co.
31 Mar 1994K941015ORMCO SYSTEM 1+ (TM)Sybron Dental Specialties
31 Mar 1994K940845SYSTEM 1Sybron Dental Specialties
21 Jan 1994K935714CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITEConfi-Dental Products Co.
8 Jul 1993K925359RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINSConfi-Dental Products Co.
17 Jun 1993K930614ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYSTWallace A. Erickson & Co.
23 Dec 1992K921283ADHESIVE, BRACKET AND TOOTH CONDITIONER RESINJeneric/Pentron, Inc.
9 Nov 1992K921044ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BONDWallace A. Erickson & Co.
27 Oct 1992K923399CHALLENGE II - PASTE ADHESIVESybron Dental Specialties
5 May 1992K921245THE BRACKET ASSEMBLY W/ SECURITY SYSTEM IISybron Dental Specialties
21 Apr 1992K921385IMPROVED SEQUENCE LIGHT CURE ADHESIVESybron Dental Specialties
21 Apr 1992K920781FLASH BONDAdvanced Orthodontics Systems, Inc.
26 Mar 1992K920534PORCELAIN PRIMERConfi-Dental Products Co.
26 Mar 1992K914317ORTHODONTIC BRACKET ADHESIVE RESIN MATERIALConfi-Dental Products Co.
17 Jan 1992K914727SEQUENCE LIGHT CURE ADHESIVESybron Dental Specialties
14 Jan 1992K913854ORTHO LIGHT CUREOrtho Source
5 Jul 1991K911286PULPDENT ORTHODONTIC BRACKET ADHESIVEPulpdent Corporation
29 May 1991K911271ADHESIVE PRECOATED BRACKETSUnitek Corp.
29 Apr 1991K904090ORTHODONTIC BONDING ADHESIVE CONTROLLancer Orthodontics, Inc.
15 Mar 1991K910803ENAMEL ETCHING GELGresco Products, Inc.
8 Dec 1989K895523PHASE II ORTHODONTIC ADHESIVEReliance Orthodontic Products, Inc.
7 Dec 1989K895522LIGHT BOND PASTE W/FLUORIDEReliance Orthodontic Products, Inc.
7 Dec 1989K895521RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE)Reliance Orthodontic Products, Inc.
27 Oct 1989K895163FORCE IIAmerican Orthodontics
20 Oct 1989K894639SKYROCK AND LIGHT SUPERBONDDent Zar, Inc.
13 Oct 1989K894565LIGHT BOND SEALANT WITH FLUORIDEReliance Orthodontic Products, Inc.
19 Sep 1989K894566MAXIMUM CURE SEALANT WITH FLUORIDEReliance Orthodontic Products, Inc.
23 Jun 1989K893396AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEMAmerican Orthodontics
21 Jun 1989K893255SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVEAmerican Orthodontics
12 Jun 1989K893037NO-MIX 30 ORTHODONTIC BONDING SYSTEMSAmerican Orthodontics
18 May 1989K891464RESILIENCE C2, RESILIENCE L3 & RESILIENCE P4Confi-Dental Products Co.
1 May 1989K890834NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTICScientific Pharmaceuticals
25 Apr 1989K890740FRS LITE FLUORIDE RELEASING SEALANTSybron Dental Specialties
3 Jan 1989K884575MAXIBONDOrtho Source
12 Oct 1988K883465ORTHO-SEALBisco, Inc.
19 Aug 1988K880562ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KITMacrochem Corp.
13 Jun 1988K880793LIGHT BONDReliance Orthodontic Products, Inc.
13 Jun 1988K880791MAXIMUM CURE SEALANTReliance Orthodontic Products, Inc.
25 Apr 1988K880766RELIANCE METAL PRIMERReliance Orthodontic Products, Inc.
18 Apr 1988K880792PLASTIC PRIMERReliance Orthodontic Products, Inc.
18 Apr 1988K880790PORCELAIN PRIMERReliance Orthodontic Products, Inc.
31 Mar 1988K880393TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVEUnitek Corp.
18 Mar 1988K874228BOND FAST NO MIX ADHESIVEAdvanced Orthodontics Systems, Inc.
29 Feb 1988K875142PHASE IIReliance Orthodontic Products, Inc.
26 Feb 1988K875144EXCEL FAST SETReliance Orthodontic Products, Inc.
26 Feb 1988K875143RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE)Reliance Orthodontic Products, Inc.
26 Feb 1988K875141EXCEL REGULAR SETReliance Orthodontic Products, Inc.
18 May 1987K871591ORMCO GEL-ETCHScientific Pharmaceuticals
21 Jan 1987K863709CHALLENGE ORTHODONTIC BONDING ADHESIVESybron Dental Specialties
24 Oct 1986K864008ACCLAIM* BRACKET ADHESIVEJohnson & Johnson Professionals, Inc.
2 May 1986K861118ORTHOJOIN, ORTHODONTIC ADHESIVEOrtho Source
17 Apr 1986K861258PERMABAND (ORTHODONTIC ADHESIVE)Ortho Source
25 Mar 1986K860959DEPENDABONDOrtho Source
13 Feb 1986K844844ESPE NIMETIC-GRIPEspe GmbH (Us)
26 Nov 1985K854050EXCEL BRACKET ADHESIVEJohnson & Johnson Professionals, Inc.
7 Nov 1985K853523VISIBLE LIGHT CURED ORTHODONTIC ADHESIVEDentsply Intl., Inc.
4 Jan 1985K844134CLEANSE N BOND IILee Pharmaceuticals
4 Jan 1985K844133CLEANSE N BOND ILee Pharmaceuticals
18 Oct 1984K843527ORTHOMITE 111 ADHESIVERocky Mountain Orthodontics, Inc.
27 Sep 1984K842448BOSWORTH SUPER BOND DENTAL ADHESIVEHarry J. Bosworth Co.
1 Sep 1983K832292SOLO-TACHDentsply Intl., Inc.
31 Aug 1983K832291AUTO-TACHDentsply Intl., Inc.
31 Aug 1983K832112NO-MIX 30 ORTHODONTIC BONDING SYSTEMScientific Pharmaceuticals
18 Jul 1983K831495CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHOScientific Pharmaceuticals
26 Jan 1983K823928TOOTH CONDITIONERDentsply Intl., Inc.
21 Jan 1983K823409HELIOSIT-ORTHODONTICVivadent (Usa), Inc.
9 Jan 1983K823851ORTHODAPTIC* BONDING ADHESIVEJohnson & Johnson Professionals, Inc.
24 Feb 1982K820092SECURE-ON-TOUCHSci-Pharm, Inc.
23 Sep 1981K812547BEAUBONSci-Pharm, Inc.
21 Apr 1981K810959SECURESci-Pharm, Inc.
21 Apr 1981K810715SECURESci-Pharm, Inc.
24 Mar 1981K810517INSTA-BONDLee Pharmaceuticals
12 Feb 1981K810241CRYSTAL-BONDAmerican Ormco
10 Feb 1981K810210MAGIC-TOUCHSci-Pharm, Inc.
10 Apr 1980K800392BRACKET BONDING SYSTEM METAL & PLASTICAmerican Dental Research
27 Nov 1979K7920031 STEPBetta Dental, Inc.
10 Aug 1979K791132SCI-PHARM ORTHODONTIC ADHESIVEScientific Pharmaceuticals
6 Jul 1979K790962SEAL & BOND DIRECT BONDING ORTHODONTICScientific Pharmaceuticals
28 Mar 1978K780334ADHESIVE, BRACKET AND CONDITIONER RESINRocky Mountain Orthodontics, Inc.
17 Jan 1978K780028ORTHODONTIC. PLASTIC BRACKET PRIMER3M Company
3 Jan 1978K772126TEMP. BRIDGE, POSTERIOR 3-UNITLee Pharmaceuticals
20 Oct 1977K771883REPLICA ACID-ETCHHoyt Laboratories
24 Jun 1977K771076ORTHODONTIC BRACKET ADHESIVELee Pharmaceuticals
23 Aug 1976K760378CEMENT, RESIN DENTAL (AUTO-TACH)L.D. Caulk Co.
23 Aug 1976K760376CEMENT, RESIN DENTAL (SOLO-TACH)L.D. Caulk Co.

Official records: FDA product classification for DYH · 21 CFR 872.3750.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026