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 |
| 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 |
| K014142 | 3M UNITEK | UNITE BONDING ADHESIVE | 02/28/2002 |
| K113197 | 3M UNITEK CORPORATION | APC FLASH-FREE ADHESIVE | 02/02/2012 |
| K234043 | 3M Unitek Orthodontic Products | 3MÖ TransbondÖ Orthodontic Adhesive | 12/22/2023 |
| K020648 | ALLODEX SYSTEMS | GRIDLOCK 195 ADHESIVE | 05/01/2002 |
| K160782 | American Orthodontics | BracePaste Adhesive | 10/14/2016 |
| K202276 | American Orthodontics | BracePaste Band and Build LC | 08/14/2020 |
| K242537 | American Orthodontics Corp. | BracePaste Fluoride Sealant | 08/27/2024 |
| K010544 | APEX DENTAL MATERIALS, INC. | VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE | 08/10/2001 |
| 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 |
| 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 |
| K955329 | CONFI-DENTAL PRODUCTS CO. | RESILIENCE M5 PROTECTION PLUS | 03/28/1996 |
| 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 |
| 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 |
| K192682 | Dentscare Ltda | Orthocem, Ortho Bite | 08/14/2020 |
| K081291 | DENTSPLY INTERNTIONAL | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION | 05/22/2008 |
| 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 |
| K093221 | DENTSPLY INTL., INC. | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II | 10/30/2009 |
| K011521 | FIRST SCIENTIFIC LIMITED | ORTHO VLC; ORTHO VLC CAPSULE | 08/01/2001 |
| K981036 | GAC INTL., INC. | SMARTBOND | 04/05/1999 |
| 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 |
| 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 |
| K210115 | Largent Health, LLC | FiteBac CC OrthoSeal | 07/29/2021 |
| K072978 | MICERIUM S.P.A. | TENDER ORTHO BOND-ENA BOND-ENA ETCH | 01/17/2008 |
| K120619 | NOVOCOL, INC. | ORTHODONTIC FLOWABLE BRACKET ADHESIVE | 05/21/2012 |
| K061481 | ORMCO CORP. | GRENGLOO | 07/06/2006 |
| K250015 | Ormco Corporation | OrmcoÖ EtchFree Bonding System, OrmcoÖ EtchFree Bonding Primer, OrmcoÖ EtchFree Adhesive | 01/03/2025 |
| 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 |
| K014133 | PULPDENT CORP. | PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE | 03/14/2002 |
| K020115 | PULPDENT CORP. | PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM | 02/28/2002 |
| 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 |
| K193388 | Reliance Orthodontic Products Inc. | GlassLok Kits, GlassLok Powder, GlassLok Liquid | 04/27/2020 |
| 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 |
| K083051 | RELIANCE ORTHODONTIC PRODUCTS, INC. | FLOWTAIN & FLOWTAIN LV | 02/20/2009 |
| K001048 | RELIANCE ORTHODONTIC PRODUCTS, INC. | LIGHT BOND (QUICK CURE) | 04/27/2000 |
| K101951 | RELIANCE ORTHODONTIC PRODUCTS, INC. | LIGHT CURE RETAINER | 10/26/2010 |
| K111814 | RELIANCE ORTHODONTIC PRODUCTS, INC. | PADLOCK | 09/14/2011 |
| K071590 | RELIANCE ORTHODONTIC PRODUCTS, INC. | THERMA-CURE | 07/31/2007 |
| K031420 | S & C POLYMER GMBH | S & C -BRACKET ADHESIVES | 08/20/2003 |
| K001446 | SCIENTIFIC PHARMACEUTICALS, INC. | LIGHT-CURED ORTHODONTIC BAND CEMENT | 07/21/2000 |
| 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 |
| K214054 | TP Orthodontics, Inc. | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 | 10/14/2022 |
| 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 |
| K231817 | VOCO GmbH | AlignerFlow LC | 12/01/2023 |
| K183147 | VOCO GmbH | BrackFix | 03/01/2019 |
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