Atlas FDA

DYH

194 FDA 510(k) clearances · Product code

66 daysmedian time to decision
154 days90th percentile
194clearances measured

FDA profile

Official device name
Adhesive, Bracket And Tooth Conditioner, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3750
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2001: 2 · 2002: 1 · 2003: 2 · 2004: 3 · 2007: 2 · 2010: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
OrthoFit (K261129)Spident Co., Ltd.2026-07-02
BracePaste Prime Plus (K261840)American Orthodontics2026-06-03
Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive (K250015)Ormco Corporation2025-01-03
BracePaste Fluoride Sealant (K242537)American Orthodontics Corp.2024-08-27
3M™ Transbond™ Orthodontic Adhesive (K234043)3M Unitek Orthodontic Products2023-12-22
AlignerFlow LC (K231817)Voco GmbH2023-12-01
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 (K214054)Tp Orthodontics, Inc.2022-10-14
FiteBac CC OrthoSeal (K210115)Largent Health, LLC2021-07-29
BracePaste Band and Build LC (K202276)American Orthodontics2020-08-14
Orthocem, Ortho Bite (K192682)Dentscare Ltda2020-08-14
GlassLok Kits, GlassLok Powder, GlassLok Liquid (K193388)Reliance Orthodontic Products, Inc.2020-04-27
BrackFix (K183147)Voco GmbH2019-03-01
OBA-MCP, Orthodontic Bracket Adhesive with MCP (K173020)Pulpdent Corporation2018-01-17
BracePaste Adhesive (K160782)American Orthodontics2016-10-14
Quantum LB (K161684)Reliance Orthodontic Products, Inc.2016-10-06
GC Ortho Connect, GC Ortho Etching Gel (K150128)Gc Orthodontics America, Inc.2015-07-16
GC KommonBase (K143667)Gc Orthodontics America, Inc.2015-05-07
DMRC Self-Cure Bracket Adhesive One Step and Primer (K142886)Danville Materials, LLC2015-03-18
DMRC Dual Cure Orthodontic Band Cement (K142881)Danville Materials, LLC2015-02-13
DMRC Light Cure Orthodontic Adhesive System (K142880)Daville Materials, LLC2015-02-04
CLEAR ALIGNER ADHESIVE (K123348)Reliance Orthodontic Products, Inc.2013-02-28
ORTHODONTIC FLOWABLE BRACKET ADHESIVE (K120619)Novocol, Inc.2012-05-21
ORTHO-1(NOT FINALIZED) (K113401)Bisco, Inc.2012-02-07
APC FLASH-FREE ADHESIVE (K113197)3M Unitek Corporation2012-02-02
PADLOCK (K111814)Reliance Orthodontic Products, Inc.2011-09-14
OPAL BAND CEMENT (K111696)Ultradent Products, Inc.2011-09-07
LIGHT CURE RETAINER (K101951)Reliance Orthodontic Products, Inc.2010-10-26
TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE (K100536)3M Unitek2010-07-27
OPAL BOND FLOW (K100301)Ultradent Products, Inc.2010-04-29
OPAL BOND MV (K094006)Ultradent Products, Inc.2010-03-23
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II (K093221)Dentsply Intl., Inc.2009-10-30
OPAL SEAL (K090355)Ultradent Products, Inc.2009-04-29
FLOWTAIN & FLOWTAIN LV (K083051)Reliance Orthodontic Products, Inc.2009-02-20
LION SE ONE STEP ORTHODONTIC ADHESIVE (K080445)Classone Orthodontics, Inc.2008-07-16
GC OPB-100 (K080724)GC America, Inc.2008-06-11
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION (K081291)Dentsply Interntional2008-05-22
GC MODELS OPA-100 AND JC-50 (K073588)GC America, Inc.2008-02-15
TRANSBOND SUPREME ADHESIVE (K073697)3M Unitek2008-02-15
TENDER ORTHO BOND-ENA BOND-ENA ETCH (K072978)Micerium S.P.A.2008-01-17
RM BOND, MODEL J032 (K072830)Pentron Clinical Technologies2007-12-04
THERMA-CURE (K071590)Reliance Orthodontic Products, Inc.2007-07-31
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM (K061252)Primus Consulting2007-02-12
GRENGLOO (K061481)Ormco Corp.2006-07-06
RELI-ON ONE STEP, ORTHODONTIC ADHESIVE (K053379)Classone Orthodontics, Inc.2006-01-25
LC BRACKET ADHESIVE SYSTEM (K050750)Dentsply Intl.2005-04-06
D3 CHROMA (K042422)Sybron Dental Specialties, Inc.2004-11-15
IDEAL 1 ORTHODONTIC BAND CEMENT (K040375)Dentsply Intl.2004-04-02
AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE (K040548)Harry J. Bosworth Co.2004-03-19
AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE (K040547)Harry J. Bosworth Co.2004-03-19
IDEAL 1 ORTHODONTIC BRACKET ADHESIVE (K033703)Dentsply Intl.2004-02-06
EVOLVE (K033551)Reliance Orthodontic Products, Inc.2003-12-16
CONTEC DUO, CONTEC LC, CONTEC LCR (K030644)Dentaurum2003-11-21
DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT (K032195)Dentaurum2003-10-07
OPTIBAND LC (K032407)Sybron Dental Specialties, Inc.2003-10-06
ENVISION (K032042)Sybron Dental Specialties, Inc.2003-09-29
DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE (K030980)Dentaurum2003-08-25
DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE (K030977)Dentaurum2003-08-25
S & C -BRACKET ADHESIVES (K031420)S & C Polymer GmbH2003-08-20
TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT (K030036)Pulpdent Corporation2003-03-12
COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM (K022224)Coltene AG2002-09-18
SOLO ORTHO 3 (K020502)Sybron Dental Specialties, Inc.2002-05-01
GRIDLOCK 195 ADHESIVE (K020648)Allodex Systems2002-05-01
GC FUJI ORTHO BAND PASTE PAK (K020578)GC America, Inc.2002-04-26
APC PLUS ADHESIVE (K020394)3M Unitek2002-04-12
PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT (K014138)Pulpdent Corp.2002-03-14
PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE (K014133)Pulpdent Corp.2002-03-14
UNITE BONDING ADHESIVE (K014142)3M Unitek2002-02-28
PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM (K020115)Pulpdent Corp.2002-02-28
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE (K014059)Pulpdent Corp.2002-02-27
PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM (K012673)Prime Dental Manufacturing, Inc.2001-10-24
FIRST SPEP (K012032)Bisco, Inc.2001-09-17
VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE (K010544)Apex Dental Materials, Inc.2001-08-10
ORTHO VLC; ORTHO VLC CAPSULE (K011521)First Scientific Limited2001-08-01
IMPROVED ENLIGHT LV (K001881)Sybron Dental Specialties, Inc.2000-08-22
LIGHT-CURED ORTHODONTIC BAND CEMENT (K001446)Scientific Pharmaceuticals, Inc.2000-07-21
LIGHT BOND (QUICK CURE) (K001048)Reliance Orthodontic Products, Inc.2000-04-27
SOLO ORTHO 2 (K994309)Sybron Dental Specialties, Inc.2000-03-17
SOLO ORTHO (K990743)Sybron Dental Specialties, Inc.1999-06-04
SMARTBOND (K981036)Gac Intl., Inc.1999-04-05
SOLO PLUS ORTHO (K990252)Sybron Dental Specialties, Inc.1999-02-25
ENLIGHT LV (K984362)Sybron Dental Specialties, Inc.1999-01-21
ENLIGHT-2 (K984217)Sybron Dental Specialties, Inc.1999-01-20
GC FUJI ORTHO LC (K981461)GC America, Inc.1998-06-25
ENLIGHT (TENTATIVE NAME) (K972890)Sybron Dental Specialties, Inc.1997-09-16
ORTHO-ONE (K962946)Bisco, Inc.1996-09-03
GC FUJI ORTHO (K961417)GC America, Inc.1996-05-24
RESILIENCE M5 PROTECTION PLUS (K955329)Confi-Dental Products Co.1996-03-28
AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM (K954374)American Dental Products, Inc.1995-10-19
AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE (K954373)American Dental Products, Inc.1995-10-19
AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE (K954372)American Dental Products, Inc.1995-10-17
AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM (K954333)American Dental Products, Inc.1995-10-12
AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM W/FLUORIDE (K954244)American Dental Products, Inc.1995-10-12
LIGHT-CURE PC (K952856)Midwest Orthodontic Mfg.1995-09-12
PC-LOCK (K952855)Midwest Orthodontic Mfg.1995-09-08
LIGHT-CURE (K952858)Midwest Orthodontic Mfg.1995-09-05
PRO-LOCK (K952857)Midwest Orthodontic Mfg.1995-09-05
PULPDENT TOUCHDOWN (K953217)Pulpdent Corp.1995-08-25
PULPDENT GLASS IONOMER CEMENTS (K952854)Pulpdent Corp.1995-07-14
RIGHT-ON ADHESIVE BOUDING SYSTEM (K952643)Tp Orthodontics, Inc.1995-07-11
VILA (K951381)Health-Dent Intl., Inc.1995-04-27
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