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 |
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 |
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 |
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 |
K183147 |
VOCO GmbH |
BrackFix |
03/01/2019 |