FDA 510(k) Applications for Medical Device Product Code "DYH"
(Adhesive, Bracket And Tooth Conditioner, Resin)

FDA 510(k) Number Applicant Device Name Decision Date
K780028 3M COMPANY ORTHODONTIC. PLASTIC BRACKET PRIMER 01/17/1978
K020394 3M UNITEK APC PLUS ADHESIVE 04/12/2002
K100536 3M UNITEK TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE 07/27/2010
K073697 3M UNITEK TRANSBOND SUPREME ADHESIVE 02/15/2008
K950514 3M UNITEK TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT 03/07/1995
K014142 3M UNITEK UNITE BONDING ADHESIVE 02/28/2002
K113197 3M UNITEK CORPORATION APC FLASH-FREE ADHESIVE 02/02/2012
K920781 ADVANCED ORTHODONTICS SYSTEMS, INC. "FLASH BOND" 04/21/1992
K874228 ADVANCED ORTHODONTICS SYSTEMS, INC. BOND FAST NO MIX ADHESIVE 03/18/1988
K020648 ALLODEX SYSTEMS GRIDLOCK 195 ADHESIVE 05/01/2002
K950512 AMERICAN DENTAL PRODUCTS, INC. AMERICAN DENTAL PRODUCTS (ADP), FLUORIDE RELEASING GLASS IONOMER BAND CEMENT 03/07/1995
K954244 AMERICAN DENTAL PRODUCTS, INC. AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM W/FLUORIDE 10/12/1995
K954333 AMERICAN DENTAL PRODUCTS, INC. AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM 10/12/1995
K954374 AMERICAN DENTAL PRODUCTS, INC. AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM 10/19/1995
K954373 AMERICAN DENTAL PRODUCTS, INC. AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE 10/19/1995
K954372 AMERICAN DENTAL PRODUCTS, INC. AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE 10/17/1995
K800392 AMERICAN DENTAL RESEARCH BRACKET BONDING SYSTEM METAL & PLASTIC 04/10/1980
K810241 AMERICAN ORMCO CRYSTAL-BOND 02/12/1981
K893396 AMERICAN ORTHODONTICS AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM 06/23/1989
K160782 American Orthodontics BracePaste Adhesive 10/14/2016
K895163 AMERICAN ORTHODONTICS FORCE II 10/27/1989
K893037 AMERICAN ORTHODONTICS NO-MIX 30 ORTHODONTIC BONDING SYSTEMS 06/12/1989
K893255 AMERICAN ORTHODONTICS SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE 06/21/1989
K010544 APEX DENTAL MATERIALS, INC. VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE 08/10/2001
K792003 BETTA DENTAL, INC. "1 STEP 11/27/1979
K012032 BISCO, INC. FIRST SPEP 09/17/2001
K113401 BISCO, INC. ORTHO-1(NOT FINALIZED) 02/07/2012
K962946 BISCO, INC. ORTHO-ONE 09/03/1996
K883465 BISCO, INC. ORTHO-SEAL 10/12/1988
K080445 CLASSONE ORTHODONTICS, INC. LION SE ONE STEP ORTHODONTIC ADHESIVE 07/16/2008
K053379 CLASSONE ORTHODONTICS, INC. RELI-ON ONE STEP, ORTHODONTIC ADHESIVE 01/25/2006
K022224 COLTENE AG COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM 09/18/2002
K935714 CONFI-DENTAL PRODUCTS CO. CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE 01/21/1994
K914317 CONFI-DENTAL PRODUCTS CO. ORTHODONTIC BRACKET ADHESIVE RESIN MATERIAL 03/26/1992
K920534 CONFI-DENTAL PRODUCTS CO. PORCELAIN PRIMER 03/26/1992
K891464 CONFI-DENTAL PRODUCTS CO. RESILIENCE C2, RESILIENCE L3 & RESILIENCE P4 05/18/1989
K955329 CONFI-DENTAL PRODUCTS CO. RESILIENCE M5 PROTECTION PLUS 03/28/1996
K925359 CONFI-DENTAL PRODUCTS CO. RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS 07/08/1993
K142881 DANVILLE MATERIALS, LLC. DMRC Dual Cure Orthodontic Band Cement 02/13/2015
K142886 DANVILLE MATERIALS, LLC. DMRC Self-Cure Bracket Adhesive One Step and Primer 03/18/2015
K142880 Daville Materials LLC DMRC Light Cure Orthodontic Adhesive System 02/04/2015
K894639 DENT ZAR, INC. SKYROCK AND LIGHT SUPERBOND 10/20/1989
K030644 DENTAURUM CONTEC DUO, CONTEC LC, CONTEC LCR 11/21/2003
K032195 DENTAURUM DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT 10/07/2003
K030977 DENTAURUM DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE 08/25/2003
K030980 DENTAURUM DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE 08/25/2003
K081291 DENTSPLY INTERNTIONAL PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION 05/22/2008
K832291 DENTSPLY INTL. AUTO-TACH 08/31/1983
K040375 DENTSPLY INTL. IDEAL 1 ORTHODONTIC BAND CEMENT 04/02/2004
K033703 DENTSPLY INTL. IDEAL 1 ORTHODONTIC BRACKET ADHESIVE 02/06/2004
K050750 DENTSPLY INTL. LC BRACKET ADHESIVE SYSTEM 04/06/2005
K832292 DENTSPLY INTL. SOLO-TACH 09/01/1983
K823928 DENTSPLY INTL. TOOTH CONDITIONER 01/26/1983
K853523 DENTSPLY INTL. VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE 11/07/1985
K093221 DENTSPLY INTL., INC. PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II 10/30/2009
K844844 ESPE GMBH (US) ESPE NIMETIC-GRIP 02/13/1986
K011521 FIRST SCIENTIFIC LIMITED ORTHO VLC; ORTHO VLC CAPSULE 08/01/2001
K981036 GAC INTL., INC. SMARTBOND 04/05/1999
K950556 GC AMERICA, INC. FUJI ORTHO LC 03/08/1995
K961417 GC AMERICA, INC. GC FUJI ORTHO 05/24/1996
K020578 GC AMERICA, INC. GC FUJI ORTHO BAND PASTE PAK 04/26/2002
K981461 GC AMERICA, INC. GC FUJI ORTHO LC 06/25/1998
K073588 GC AMERICA, INC. GC MODELS OPA-100 AND JC-50 02/15/2008
K080724 GC AMERICA, INC. GC OPB-100 06/11/2008
K143667 GC Orthodontics America Inc. GC KommonBase 05/07/2015
K150128 GC Orthodontics America Inc. GC Ortho Connect, GC Ortho Etching Gel 07/16/2015
K910803 GRESCO PRODUCTS, INC. ENAMEL ETCHING GEL 03/15/1991
K040547 HARRY J. BOSWORTH CO. AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE 03/19/2004
K040548 HARRY J. BOSWORTH CO. AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE 03/19/2004
K842448 HARRY J. BOSWORTH CO. BOSWORTH SUPER BOND DENTAL ADHESIVE 09/27/1984
K951235 HEALTH-DENT INTL., INC. GIROC 04/20/1995
K951236 HEALTH-DENT INTL., INC. PRO-LOCK 04/18/1995
K951381 HEALTH-DENT INTL., INC. VILA 04/27/1995
K951380 HEALTH-DENT INTL., INC. VILA PC 04/27/1995
K771883 HOYT LABORATORIES REPLICA ACID-ETCH 10/20/1977
K921283 JENERIC/PENTRON, INC. ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN 12/23/1992
K864008 JOHNSON & JOHNSON PROFESSIONALS, INC. ACCLAIM* BRACKET ADHESIVE 10/24/1986
K854050 JOHNSON & JOHNSON PROFESSIONALS, INC. EXCEL BRACKET ADHESIVE 11/26/1985
K823851 JOHNSON & JOHNSON PROFESSIONALS, INC. ORTHODAPTIC* BONDING ADHESIVE 01/09/1983
K760378 L.D. CAULK CO. CEMENT, RESIN DENTAL (AUTO-TACH) 08/23/1976
K760376 L.D. CAULK CO. CEMENT, RESIN DENTAL (SOLO-TACH) 08/23/1976
K904090 LANCER ORTHODONTICS, INC. ORTHODONTIC BONDING ADHESIVE CONTROL 04/29/1991
K844133 LEE PHARMACEUTICALS CLEANSE N BOND I 01/04/1985
K844134 LEE PHARMACEUTICALS CLEANSE N BOND II 01/04/1985
K810517 LEE PHARMACEUTICALS INSTA-BOND 03/24/1981
K771076 LEE PHARMACEUTICALS ORTHODONTIC BRACKET ADHESIVE 06/24/1977
K772126 LEE PHARMACEUTICALS TEMP. BRIDGE, POSTERIOR 3-UNIT 01/03/1978
K880562 MACROCHEM CORP. ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT 08/19/1988
K072978 MICERIUM S.P.A. TENDER ORTHO BOND-ENA BOND-ENA ETCH 01/17/2008
K952858 MIDWEST ORTHODONTIC MFG. LIGHT-CURE 09/05/1995
K952856 MIDWEST ORTHODONTIC MFG. LIGHT-CURE PC 09/12/1995
K952855 MIDWEST ORTHODONTIC MFG. PC-LOCK 09/08/1995
K952857 MIDWEST ORTHODONTIC MFG. PRO-LOCK 09/05/1995
K120619 NOVOCOL, INC. ORTHODONTIC FLOWABLE BRACKET ADHESIVE 05/21/2012
K923399 ORMCO CORP. CHALLENGE II - PASTE ADHESIVE 10/27/1992
K863709 ORMCO CORP. CHALLENGE ORTHODONTIC BONDING ADHESIVE 01/21/1987
K890740 ORMCO CORP. FRS LITE FLUORIDE RELEASING SEALANT 04/25/1989
K061481 ORMCO CORP. GRENGLOO 07/06/2006
K921385 ORMCO CORP. IMPROVED SEQUENCE LIGHT CURE ADHESIVE 04/21/1992
K941015 ORMCO CORP. ORMCO SYSTEM 1+ (TM) 03/31/1994
K914727 ORMCO CORP. SEQUENCE LIGHT CURE ADHESIVE 01/17/1992
K921245 ORMCO CORP. THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II 05/05/1992
K946255 ORMCO CORP. THERMASET 01/27/1995
K860959 ORTHO SOURCE DEPENDABOND 03/25/1986
K884575 ORTHO SOURCE MAXIBOND 01/03/1989
K913854 ORTHO SOURCE ORTHO LIGHT CURE 01/14/1992
K861118 ORTHO SOURCE ORTHOJOIN, ORTHODONTIC ADHESIVE 05/02/1986
K861258 ORTHO SOURCE PERMABAND (ORTHODONTIC ADHESIVE) 04/17/1986
K072830 PENTRON CLINICAL TECHNOLOGIES RM BOND, MODEL J032 12/04/2007
K012673 PRIME DENTAL MANUFACTURING, INC. PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM 10/24/2001
K061252 PRIMUS CONSULTING PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM 02/12/2007
K952854 PULPDENT CORP. PULPDENT GLASS IONOMER CEMENTS 07/14/1995
K014133 PULPDENT CORP. PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE 03/14/2002
K911286 PULPDENT CORP. PULPDENT ORTHODONTIC BRACKET ADHESIVE 07/05/1991
K020115 PULPDENT CORP. PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM 02/28/2002
K953217 PULPDENT CORP. PULPDENT TOUCHDOWN 08/25/1995
K014059 PULPDENT CORP. PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE 02/27/2002
K014138 PULPDENT CORP. PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT 03/14/2002
K173020 Pulpdent Corporation OBA-MCP, Orthodontic Bracket Adhesive with MCP 01/17/2018
K030036 PULPDENT CORPORATION TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT 03/12/2003
K161684 Reliance Orthodontic Products Inc. Quantum LB 10/06/2016
K123348 RELIANCE ORTHODONTIC PRODUCTS, INC. CLEAR ALIGNER ADHESIVE 02/28/2013
K033551 RELIANCE ORTHODONTIC PRODUCTS, INC. EVOLVE 12/16/2003
K875144 RELIANCE ORTHODONTIC PRODUCTS, INC. EXCEL FAST SET 02/26/1988
K875141 RELIANCE ORTHODONTIC PRODUCTS, INC. EXCEL REGULAR SET 02/26/1988
K083051 RELIANCE ORTHODONTIC PRODUCTS, INC. FLOWTAIN & FLOWTAIN LV 02/20/2009
K880793 RELIANCE ORTHODONTIC PRODUCTS, INC. LIGHT BOND 06/13/1988
K001048 RELIANCE ORTHODONTIC PRODUCTS, INC. LIGHT BOND (QUICK CURE) 04/27/2000
K895522 RELIANCE ORTHODONTIC PRODUCTS, INC. LIGHT BOND PASTE W/FLUORIDE 12/07/1989
K894565 RELIANCE ORTHODONTIC PRODUCTS, INC. LIGHT BOND SEALANT WITH FLUORIDE 10/13/1989
K101951 RELIANCE ORTHODONTIC PRODUCTS, INC. LIGHT CURE RETAINER 10/26/2010
K880791 RELIANCE ORTHODONTIC PRODUCTS, INC. MAXIMUM CURE SEALANT 06/13/1988
K894566 RELIANCE ORTHODONTIC PRODUCTS, INC. MAXIMUM CURE SEALANT WITH FLUORIDE 09/19/1989
K111814 RELIANCE ORTHODONTIC PRODUCTS, INC. PADLOCK 09/14/2011
K875142 RELIANCE ORTHODONTIC PRODUCTS, INC. PHASE II 02/29/1988
K895523 RELIANCE ORTHODONTIC PRODUCTS, INC. PHASE II ORTHODONTIC ADHESIVE 12/08/1989
K880792 RELIANCE ORTHODONTIC PRODUCTS, INC. PLASTIC PRIMER 04/18/1988
K880790 RELIANCE ORTHODONTIC PRODUCTS, INC. PORCELAIN PRIMER 04/18/1988
K880766 RELIANCE ORTHODONTIC PRODUCTS, INC. RELIANCE METAL PRIMER 04/25/1988
K895521 RELIANCE ORTHODONTIC PRODUCTS, INC. RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE) 12/07/1989
K875143 RELIANCE ORTHODONTIC PRODUCTS, INC. RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE) 02/26/1988
K071590 RELIANCE ORTHODONTIC PRODUCTS, INC. THERMA-CURE 07/31/2007
K780334 ROCKY MOUNTAIN ORTHODONTICS, INC. ADHESIVE, BRACKET AND CONDITIONER RESIN 03/28/1978
K843527 ROCKY MOUNTAIN ORTHODONTICS, INC. ORTHOMITE 111 ADHESIVE 10/18/1984
K031420 S & C POLYMER GMBH S & C -BRACKET ADHESIVES 08/20/2003
K812547 SCI-PHARM, INC. "BEAUBON" 09/23/1981
K810959 SCI-PHARM, INC. "SECURE" 04/21/1981
K810715 SCI-PHARM, INC. "SECURE" 04/21/1981
K820092 SCI-PHARM, INC. "SECURE-ON-TOUCH" 02/24/1982
K810210 SCI-PHARM, INC. MAGIC-TOUCH 02/10/1981
K831495 SCIENTIFIC PHARMACEUTICALS, INC. CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO 07/18/1983
K001446 SCIENTIFIC PHARMACEUTICALS, INC. LIGHT-CURED ORTHODONTIC BAND CEMENT 07/21/2000
K832112 SCIENTIFIC PHARMACEUTICALS, INC. NO-MIX 30 ORTHODONTIC BONDING SYSTEM 08/31/1983
K890834 SCIENTIFIC PHARMACEUTICALS, INC. NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC 05/01/1989
K871591 SCIENTIFIC PHARMACEUTICALS, INC. ORMCO GEL-ETCH 05/18/1987
K791132 SCIENTIFIC PHARMACEUTICALS, INC. SCI-PHARM ORTHODONTIC ADHESIVE 08/10/1979
K790962 SCIENTIFIC PHARMACEUTICALS, INC. SEAL & BOND DIRECT BONDING ORTHODONTIC 07/06/1979
K042422 SYBRON DENTAL SPECIALTIES, INC. D3 CHROMA 11/15/2004
K972890 SYBRON DENTAL SPECIALTIES, INC. ENLIGHT (TENTATIVE NAME) 09/16/1997
K984362 SYBRON DENTAL SPECIALTIES, INC. ENLIGHT LV 01/21/1999
K984217 SYBRON DENTAL SPECIALTIES, INC. ENLIGHT-2 01/20/1999
K032042 SYBRON DENTAL SPECIALTIES, INC. ENVISION 09/29/2003
K001881 SYBRON DENTAL SPECIALTIES, INC. IMPROVED ENLIGHT LV 08/22/2000
K032407 SYBRON DENTAL SPECIALTIES, INC. OPTIBAND LC 10/06/2003
K990743 SYBRON DENTAL SPECIALTIES, INC. SOLO ORTHO 06/04/1999
K994309 SYBRON DENTAL SPECIALTIES, INC. SOLO ORTHO 2 03/17/2000
K020502 SYBRON DENTAL SPECIALTIES, INC. SOLO ORTHO 3 05/01/2002
K990252 SYBRON DENTAL SPECIALTIES, INC. SOLO PLUS ORTHO 02/25/1999
K940845 SYBRON DENTAL SPECIALTIES, INC. SYSTEM 1 03/31/1994
K952643 TP ORTHODONTICS, INC. RIGHT-ON ADHESIVE BOUDING SYSTEM 07/11/1995
K111696 ULTRADENT PRODUCTS, INC. OPAL BAND CEMENT 09/07/2011
K100301 ULTRADENT PRODUCTS, INC. OPAL BOND FLOW 04/29/2010
K094006 ULTRADENT PRODUCTS, INC. OPAL BOND MV 03/23/2010
K090355 ULTRADENT PRODUCTS, INC. OPAL SEAL 04/29/2009
K911271 UNITEK CORP. ADHESIVE PRECOATED BRACKETS 05/29/1991
K880393 UNITEK CORP. TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE 03/31/1988
K942742 WALLACE A. ERICKSON & CO. ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV 08/29/1994
K942727 WALLACE A. ERICKSON & CO. ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE 08/23/1994
K930614 WALLACE A. ERICKSON & CO. ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYST 06/17/1993
K921044 WALLACE A. ERICKSON & CO. ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND 11/09/1992
K935625 WALLACE A. ERICKSON & CO. ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE 08/10/1994


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