FDA Product Code
FDA Product Code DYH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3750
510(k) Clearances — 194 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261129 | OrthoFit | Spident Co., Ltd. | 2026-07-02 | Traditional | PDF ↗ |
| K261840 | BracePaste Prime Plus | American Orthodontics | 2026-06-03 | Traditional | PDF ↗ |
| K250015 | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive | Ormco Corporation | 2025-01-03 | Traditional | PDF ↗ |
| K242537 | BracePaste Fluoride Sealant | American Orthodontics Corp. | 2024-08-27 | Traditional | PDF ↗ |
| K234043 | 3M Transbond Orthodontic Adhesive | 3M Unitek Orthodontic Products | 2023-12-22 | Traditional | PDF ↗ |
| K231817 | AlignerFlow LC | Voco GmbH | 2023-12-01 | Traditional | PDF ↗ |
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 | Tp Orthodontics, Inc. | 2022-10-14 | Traditional | PDF ↗ |
| K210115 | FiteBac CC OrthoSeal | Largent Health, LLC | 2021-07-29 | Traditional | PDF ↗ |
| K202276 | BracePaste Band and Build LC | American Orthodontics | 2020-08-14 | Traditional | PDF ↗ |
| K192682 | Orthocem, Ortho Bite | Dentscare Ltda | 2020-08-14 | Traditional | PDF ↗ |
| K193388 | GlassLok Kits, GlassLok Powder, GlassLok Liquid | Reliance Orthodontic Products, Inc. | 2020-04-27 | Traditional | PDF ↗ |
| K183147 | BrackFix | Voco GmbH | 2019-03-01 | Traditional | PDF ↗ |
| K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCP | Pulpdent Corporation | 2018-01-17 | Traditional | PDF ↗ |
| K160782 | BracePaste Adhesive | American Orthodontics | 2016-10-14 | Traditional | PDF ↗ |
| K161684 | Quantum LB | Reliance Orthodontic Products, Inc. | 2016-10-06 | Traditional | PDF ↗ |
| K150128 | GC Ortho Connect, GC Ortho Etching Gel | Gc Orthodontics America, Inc. | 2015-07-16 | Traditional | PDF ↗ |
| K143667 | GC KommonBase | Gc Orthodontics America, Inc. | 2015-05-07 | Traditional | PDF ↗ |
| K142886 | DMRC Self-Cure Bracket Adhesive One Step and Primer | Danville Materials, LLC | 2015-03-18 | Traditional | PDF ↗ |
| K142881 | DMRC Dual Cure Orthodontic Band Cement | Danville Materials, LLC | 2015-02-13 | Traditional | PDF ↗ |
| K142880 | DMRC Light Cure Orthodontic Adhesive System | Daville Materials, LLC | 2015-02-04 | Traditional | PDF ↗ |
| K123348 | CLEAR ALIGNER ADHESIVE | Reliance Orthodontic Products, Inc. | 2013-02-28 | Traditional | PDF ↗ |
| K120619 | ORTHODONTIC FLOWABLE BRACKET ADHESIVE | Novocol, Inc. | 2012-05-21 | Abbreviated | PDF ↗ |
| K113401 | ORTHO-1(NOT FINALIZED) | Bisco, Inc. | 2012-02-07 | Traditional | PDF ↗ |
| K113197 | APC FLASH-FREE ADHESIVE | 3M Unitek Corporation | 2012-02-02 | Traditional | PDF ↗ |
| K111814 | PADLOCK | Reliance Orthodontic Products, Inc. | 2011-09-14 | Special | PDF ↗ |
| K111696 | OPAL BAND CEMENT | Ultradent Products, Inc. | 2011-09-07 | Traditional | PDF ↗ |
| K101951 | LIGHT CURE RETAINER | Reliance Orthodontic Products, Inc. | 2010-10-26 | Traditional | PDF ↗ |
| K100536 | TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE | 3M Unitek | 2010-07-27 | Traditional | PDF ↗ |
| K100301 | OPAL BOND FLOW | Ultradent Products, Inc. | 2010-04-29 | Traditional | PDF ↗ |
| K094006 | OPAL BOND MV | Ultradent Products, Inc. | 2010-03-23 | Traditional | PDF ↗ |
| K093221 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II | Dentsply Intl., Inc. | 2009-10-30 | Special | PDF ↗ |
| K090355 | OPAL SEAL | Ultradent Products, Inc. | 2009-04-29 | Traditional | PDF ↗ |
| K083051 | FLOWTAIN & FLOWTAIN LV | Reliance Orthodontic Products, Inc. | 2009-02-20 | Traditional | PDF ↗ |
| K080445 | LION SE ONE STEP ORTHODONTIC ADHESIVE | Classone Orthodontics, Inc. | 2008-07-16 | Traditional | PDF ↗ |
| K080724 | GC OPB-100 | GC America, Inc. | 2008-06-11 | Traditional | PDF ↗ |
| K081291 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION | Dentsply Interntional | 2008-05-22 | Special | PDF ↗ |
| K073588 | GC MODELS OPA-100 AND JC-50 | GC America, Inc. | 2008-02-15 | Traditional | PDF ↗ |
| K073697 | TRANSBOND SUPREME ADHESIVE | 3M Unitek | 2008-02-15 | Traditional | PDF ↗ |
| K072978 | TENDER ORTHO BOND-ENA BOND-ENA ETCH | Micerium S.P.A. | 2008-01-17 | Traditional | PDF ↗ |
| K072830 | RM BOND, MODEL J032 | Pentron Clinical Technologies | 2007-12-04 | Traditional | PDF ↗ |
| K071590 | THERMA-CURE | Reliance Orthodontic Products, Inc. | 2007-07-31 | Traditional | PDF ↗ |
| K061252 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM | Primus Consulting | 2007-02-12 | Traditional | PDF ↗ |
| K061481 | GRENGLOO | Ormco Corp. | 2006-07-06 | Traditional | PDF ↗ |
| K053379 | RELI-ON ONE STEP, ORTHODONTIC ADHESIVE | Classone Orthodontics, Inc. | 2006-01-25 | Traditional | PDF ↗ |
| K050750 | LC BRACKET ADHESIVE SYSTEM | Dentsply Intl. | 2005-04-06 | Special | PDF ↗ |
| K042422 | D3 CHROMA | Sybron Dental Specialties, Inc. | 2004-11-15 | Traditional | PDF ↗ |
| K040375 | IDEAL 1 ORTHODONTIC BAND CEMENT | Dentsply Intl. | 2004-04-02 | Traditional | PDF ↗ |
| K040547 | AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE | Harry J. Bosworth Co. | 2004-03-19 | Traditional | PDF ↗ |
| K040548 | AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE | Harry J. Bosworth Co. | 2004-03-19 | Traditional | PDF ↗ |
| K033703 | IDEAL 1 ORTHODONTIC BRACKET ADHESIVE | Dentsply Intl. | 2004-02-06 | Traditional | PDF ↗ |
| K033551 | EVOLVE | Reliance Orthodontic Products, Inc. | 2003-12-16 | Special | PDF ↗ |
| K030644 | CONTEC DUO, CONTEC LC, CONTEC LCR | Dentaurum | 2003-11-21 | Traditional | PDF ↗ |
| K032195 | DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT | Dentaurum | 2003-10-07 | Traditional | PDF ↗ |
| K032407 | OPTIBAND LC | Sybron Dental Specialties, Inc. | 2003-10-06 | Traditional | PDF ↗ |
| K032042 | ENVISION | Sybron Dental Specialties, Inc. | 2003-09-29 | Traditional | PDF ↗ |
| K030980 | DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE | Dentaurum | 2003-08-25 | Traditional | PDF ↗ |
| K030977 | DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE | Dentaurum | 2003-08-25 | Traditional | PDF ↗ |
| K031420 | S & C -BRACKET ADHESIVES | S & C Polymer GmbH | 2003-08-20 | Traditional | PDF ↗ |
| K030036 | TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT | Pulpdent Corporation | 2003-03-12 | Traditional | PDF ↗ |
| K022224 | COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM | Coltene AG | 2002-09-18 | Traditional | PDF ↗ |
| K020648 | GRIDLOCK 195 ADHESIVE | Allodex Systems | 2002-05-01 | Traditional | PDF ↗ |
| K020502 | SOLO ORTHO 3 | Sybron Dental Specialties, Inc. | 2002-05-01 | Traditional | PDF ↗ |
| K020578 | GC FUJI ORTHO BAND PASTE PAK | GC America, Inc. | 2002-04-26 | Traditional | PDF ↗ |
| K020394 | APC PLUS ADHESIVE | 3M Unitek | 2002-04-12 | Traditional | PDF ↗ |
| K014133 | PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE | Pulpdent Corp. | 2002-03-14 | Traditional | PDF ↗ |
| K014138 | PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT | Pulpdent Corp. | 2002-03-14 | Traditional | PDF ↗ |
| K014142 | UNITE BONDING ADHESIVE | 3M Unitek | 2002-02-28 | Traditional | PDF ↗ |
| K020115 | PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM | Pulpdent Corp. | 2002-02-28 | Traditional | PDF ↗ |
| K014059 | PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE | Pulpdent Corp. | 2002-02-27 | Traditional | PDF ↗ |
| K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | Prime Dental Manufacturing, Inc. | 2001-10-24 | Traditional | PDF ↗ |
| K012032 | FIRST SPEP | Bisco, Inc. | 2001-09-17 | Traditional | PDF ↗ |
| K010544 | VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE | Apex Dental Materials, Inc. | 2001-08-10 | Traditional | PDF ↗ |
| K011521 | ORTHO VLC; ORTHO VLC CAPSULE | First Scientific Limited | 2001-08-01 | Traditional | PDF ↗ |
| K001881 | IMPROVED ENLIGHT LV | Sybron Dental Specialties, Inc. | 2000-08-22 | Traditional | PDF ↗ |
| K001446 | LIGHT-CURED ORTHODONTIC BAND CEMENT | Scientific Pharmaceuticals, Inc. | 2000-07-21 | Traditional | PDF ↗ |
| K001048 | LIGHT BOND (QUICK CURE) | Reliance Orthodontic Products, Inc. | 2000-04-27 | Traditional | PDF ↗ |
| K994309 | SOLO ORTHO 2 | Sybron Dental Specialties, Inc. | 2000-03-17 | Traditional | PDF ↗ |
| K990743 | SOLO ORTHO | Sybron Dental Specialties, Inc. | 1999-06-04 | Traditional | PDF ↗ |
| K981036 | SMARTBOND | Gac Intl., Inc. | 1999-04-05 | Traditional | PDF ↗ |
| K990252 | SOLO PLUS ORTHO | Sybron Dental Specialties, Inc. | 1999-02-25 | Traditional | PDF ↗ |
| K984362 | ENLIGHT LV | Sybron Dental Specialties, Inc. | 1999-01-21 | Traditional | PDF ↗ |
| K984217 | ENLIGHT-2 | Sybron Dental Specialties, Inc. | 1999-01-20 | Traditional | PDF ↗ |
| K981461 | GC FUJI ORTHO LC | GC America, Inc. | 1998-06-25 | Traditional | PDF ↗ |
| K972890 | ENLIGHT (TENTATIVE NAME) | Sybron Dental Specialties, Inc. | 1997-09-16 | Traditional | PDF ↗ |
| K962946 | ORTHO-ONE | Bisco, Inc. | 1996-09-03 | Traditional | PDF ↗ |
| K961417 | GC FUJI ORTHO | GC America, Inc. | 1996-05-24 | Traditional | PDF ↗ |
| K955329 | RESILIENCE M5 PROTECTION PLUS | Confi-Dental Products Co. | 1996-03-28 | Traditional | PDF ↗ |
| K954373 | AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE | American Dental Products, Inc. | 1995-10-19 | Traditional | PDF ↗ |
| K954374 | AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM | American Dental Products, Inc. | 1995-10-19 | Traditional | PDF ↗ |
| K954372 | AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE | American Dental Products, Inc. | 1995-10-17 | Traditional | PDF ↗ |
| K954244 | AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM W/FLUORIDE | American Dental Products, Inc. | 1995-10-12 | Traditional | PDF ↗ |
| K954333 | AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM | American Dental Products, Inc. | 1995-10-12 | Traditional | PDF ↗ |
| K952856 | LIGHT-CURE PC | Midwest Orthodontic Mfg. | 1995-09-12 | Traditional | PDF ↗ |
| K952855 | PC-LOCK | Midwest Orthodontic Mfg. | 1995-09-08 | Traditional | PDF ↗ |
| K952857 | PRO-LOCK | Midwest Orthodontic Mfg. | 1995-09-05 | Traditional | PDF ↗ |
| K952858 | LIGHT-CURE | Midwest Orthodontic Mfg. | 1995-09-05 | Traditional | PDF ↗ |
| K953217 | PULPDENT TOUCHDOWN | Pulpdent Corp. | 1995-08-25 | Traditional | PDF ↗ |
| K952854 | PULPDENT GLASS IONOMER CEMENTS | Pulpdent Corp. | 1995-07-14 | Traditional | PDF ↗ |
| K952643 | RIGHT-ON ADHESIVE BOUDING SYSTEM | Tp Orthodontics, Inc. | 1995-07-11 | Traditional | PDF ↗ |
| K951380 | VILA PC | Health-Dent Intl., Inc. | 1995-04-27 | Traditional | PDF ↗ |
Product code DYH · Class II · Dental. Data: openFDA.