Prosthetic devices · 21 CFR 872 Subpart D
Resin Bracket and Tooth Conditioner Adhesive
FDA device type “Adhesive, Bracket And Tooth Conditioner, Resin”.
- Companies listing it
- 5426 makers
- Brands and models
- 199
- 510(k) clearances
- 1958 in five years
- FDA name
- Adhesive, Bracket And Tooth Conditioner, Resin
510(k) clearances per year, 1976–2026
Companies that list DYH
54 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Spident Co., Ltd. | South Korea | Maker | OrthoFit · OrthoFit Aligner | 22 | 2026 |
| Voco GmbH | Germany | Maker | AlignerFlow LC · BrackFix | 117 | 2026 |
| GC America Inc. | United States | Maker | Fuji Ortho LC · G-aenial Injectable Pro · G-aenial Injectable Pro Bulk · G-aenial Universal Injectable II · +18 | 137 | 2026 |
| Zest Anchors, LLC | United States | Maker | — | 26 | 2026 |
| Sybron Dental Specialties | United States | Maker | — | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | Opal Band Cement · Opal Bond · Opal Bond Flow · Opal Bond MV · +3 | 95 | 2026 |
| American Orthodontics | United States | Maker | BracePaste · Bracepaste - Color Change · BracePaste Band And Build LC · BracePaste Fluoride Sealant · +7 | 44 | 2026 |
| Premier Dental Products Company | United States | Maker | MultiMatch Flow Chameleon AntiMicrobial Composite | 28 | 2026 |
| Bisco, Inc. | United States | Maker | LIQUID ETCHANT · ORTHO-ONE | 88 | 2025 |
| Dentscare Ltda | Brazil | Maker | Ortho Bite · Orthocem | 10 | 2024 |
| Den-Mat Holdings, LLC | United States | Maker | Cerinate Prime · Etch 'N' Seal · Etchant · Porcelain Conditioner · +1 | 8 | 2026 |
| Tp Orthodontics, Inc. | United States | Maker | Enamel Conditioner | 5 | 2022 |
| Pulpdent Corporation | United States | Maker | OC Orthodontic Bracket Adhesive · ORTHO-CHOICE BAND-RITE · Ortho-Choice OBA | 107 | 2021 |
| Scientific Pharmaceuticals | United States | Maker | Band Secure · CuRay Eclipse · Cure-On-Touch · No-Mix 30 Orthodontic Bond System · +3 | 73 | 2020 |
| Reliance Orthodontic Products, Inc. | United States | Maker | Aqua Bond · Assure · Bonding Resin · Clear Aligner Adhesive · +24 | 32 | 2021 |
| S & C Polymer GmbH | Germany | Maker | — | 20 | 2009 |
| Prime Dental Manufacturing, Inc. | United States | Maker | Prime-Dent Dual Cure Glass Ionomer Band Cement · Prime-Dent Light Cure Glass Ionomer Band Cement · Prime-Dent Megaset · Prime-Dent One Step Orthodontic Adhesive · +1 | 9 | 2012 |
| Micerium S.P.A. | Italy | Maker | ENA BOND · ENA ETCH · Ena Seal · TENDER ORTHO BOND | 6 | 2011 |
| Dental Technologies, Inc. | United States | Maker | Adhesive, Bracket&Conditioner Resin · Alpha-Dent Light Cure Bracket Adhesive · Alpha-Dent Paste & Paste Bracket Adhesive | 2 | 2013 |
| Gestenco International AB | Sweden | Maker | — | 1 | 2005 |
| Dentaurum GmbH & Co. KG | Germany | Maker | ConTec · ConTec LC · ConTec LCR · ConTec SE · +2 | — | — |
| B.J.M. Laboratories Ltd | Israel | Maker | HIGH-Q-BOND · HIGH-Q-BOND BAND CEMENT · HIGH-Q-BOND BRACKET ADHESIVE · HIGH-Q-BOND BRACKET comprising PRIMER, LIGHT CURE ADHESIVE, ETCHANT · +14 | — | — |
| Solventum US LLC | United States | Maker | Transbond LR · Transbond Supreme Adhesive, · Transbond Supreme Low Viscosity Adh · Transbond Supreme LV Adhesive, · +3 | — | — |
| medmix Deutschland GmbH | Germany | Maker | — | — | — |
| Conamco | United States | Maker | Crushed Quartz | — | — |
| MANI Medical Germany GmbH | Germany | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | Adhere" Enamel Etch Conditioner · Adhere" Light Cure Adhesive 5g Syringe · Adhere" Light Cure Adhesive Kit · Adhere" Light Cure Adhesive Primer · +7 | 23 | 2025 |
| Cosmedent, Inc. | United States | Repacker / relabeler | CompositeEtch | 27 | 2024 |
| Dent Zar, Inc. | United States | Repacker / relabeler | Skyrock | 12 | 1996 |
| GC Orthodontics | United States | Manufacturer | GC KommonBase · GC Ortho Connect & GC Ortho Etching Gel | 2 | 2015 |
| Synca Marketing | Canada | Foreign exporter | Tender Ortho Bond-Ena Bond-Ena Etch | 1 | 2010 |
| Rmo, Inc. | United States | Manufacturer | Adhesive Orthodontic Bracket and Tooth Conditioner Resin - TruLock | 1 | 1990 |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Contract manufacturer | Fuji Ortho LC · Fuji Ortho SC · Light Bond · liquid etch · +6 | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN · GC FUJI ORTHO BAND PASTE REFILL | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Adhesive · Adhesive, Bracket · TransBond | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Adhesive, Resin, Composite | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | acid etch and accessories · Adhesive bonding system · Devon Bond - light cure · Devondent orthodontic Adhesive - light cure · +8 | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Adhesive · Adhesive, Bracket · Unitek | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Fuji Ortho kit · Transbond | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Band-Guard | — | — |
| Csy International LLC | United States | Repacker / relabeler | J&J ORTHODONTICS | — | — |
| Aditek do Brasil SA | Brazil | Contract manufacturer | — | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| Specialty Appliances, LLC | United States | Manufacturer | — | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | Adhesive Resin Bracket and Tooth Conditioner · Tooth Shade Resin Material | — | — |
| Viarden Lab LLC | United States | Manufacturer for export | ION GLASS ORTHO, ORTHO LUX | — | — |
| Dentonics Inc | United States | Repacker / relabeler | Master-Dent | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| O&S Dental Inc | United States | Manufacturer for export | OrthoVita Etchant Liquid · OrthoVita Light Cure Band Cement · OrthoVita Light Cure Orthodontic Adhesive · OrthoVita Light Cure Primer | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Frontier Dental Supply Inc | Canada | Foreign exporter | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 13 Oct 2026 | K262433 | OrthoFit Aligner (OrthoFit Aligner A2) | Spident Co., Ltd. |
| 2 Jul 2026 | K261129 | OrthoFit | Spident Co., Ltd. |
| 3 Jun 2026 | K261840 | BracePaste Prime Plus | American Orthodontics |
| 3 Jan 2025 | K250015 | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive | Sybron Dental Specialties |
| 27 Aug 2024 | K242537 | BracePaste Fluoride Sealant | American Orthodontics |
| 22 Dec 2023 | K234043 | 3M Transbond Orthodontic Adhesive | 3M Unitek Orthodontic Products |
| 1 Dec 2023 | K231817 | AlignerFlow LC | Voco GmbH |
| 14 Oct 2022 | K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 | Tp Orthodontics, Inc. |
| 29 Jul 2021 | K210115 | FiteBac CC OrthoSeal | Largent Health, LLC |
| 14 Aug 2020 | K202276 | BracePaste Band and Build LC | American Orthodontics |
| 14 Aug 2020 | K192682 | Orthocem, Ortho Bite | Dentscare Ltda |
| 27 Apr 2020 | K193388 | GlassLok Kits, GlassLok Powder, GlassLok Liquid | Reliance Orthodontic Products, Inc. |
| 1 Mar 2019 | K183147 | BrackFix | Voco GmbH |
| 17 Jan 2018 | K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCP | Pulpdent Corporation |
| 14 Oct 2016 | K160782 | BracePaste Adhesive | American Orthodontics |
| 6 Oct 2016 | K161684 | Quantum LB | Reliance Orthodontic Products, Inc. |
| 16 Jul 2015 | K150128 | GC Ortho Connect, GC Ortho Etching Gel | GC Orthodontics |
| 7 May 2015 | K143667 | GC KommonBase | GC Orthodontics |
| 18 Mar 2015 | K142886 | DMRC Self-Cure Bracket Adhesive One Step and Primer | Danville Materials, LLC |
| 13 Feb 2015 | K142881 | DMRC Dual Cure Orthodontic Band Cement | Danville Materials, LLC |
| 4 Feb 2015 | K142880 | DMRC Light Cure Orthodontic Adhesive System | Daville Materials, LLC |
| 28 Feb 2013 | K123348 | CLEAR ALIGNER ADHESIVE | Reliance Orthodontic Products, Inc. |
| 21 May 2012 | K120619 | ORTHODONTIC FLOWABLE BRACKET ADHESIVE | Novocol, Inc. |
| 7 Feb 2012 | K113401 | ORTHO-1(NOT FINALIZED) | Bisco, Inc. |
| 2 Feb 2012 | K113197 | APC FLASH-FREE ADHESIVE | 3M Unitek Corporation |
| 14 Sep 2011 | K111814 | PADLOCK | Reliance Orthodontic Products, Inc. |
| 7 Sep 2011 | K111696 | OPAL BAND CEMENT | Ultradent Products, Inc. |
| 26 Oct 2010 | K101951 | LIGHT CURE RETAINER | Reliance Orthodontic Products, Inc. |
| 27 Jul 2010 | K100536 | TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE | 3M Unitek Corporation |
| 29 Apr 2010 | K100301 | OPAL BOND FLOW | Ultradent Products, Inc. |
| 23 Mar 2010 | K094006 | OPAL BOND MV | Ultradent Products, Inc. |
| 30 Oct 2009 | K093221 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II | Dentsply Intl., Inc. |
| 29 Apr 2009 | K090355 | OPAL SEAL | Ultradent Products, Inc. |
| 20 Feb 2009 | K083051 | FLOWTAIN & FLOWTAIN LV | Reliance Orthodontic Products, Inc. |
| 16 Jul 2008 | K080445 | LION SE ONE STEP ORTHODONTIC ADHESIVE | Classone Orthodontics, Inc. |
| 11 Jun 2008 | K080724 | GC OPB-100 | GC America Inc. |
| 22 May 2008 | K081291 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION | Dentsply Interntional |
| 15 Feb 2008 | K073697 | TRANSBOND SUPREME ADHESIVE | 3M Unitek Corporation |
| 15 Feb 2008 | K073588 | GC MODELS OPA-100 AND JC-50 | GC America Inc. |
| 17 Jan 2008 | K072978 | TENDER ORTHO BOND-ENA BOND-ENA ETCH | Micerium S.P.A. |
| 4 Dec 2007 | K072830 | RM BOND, MODEL J032 | Pentron Clinical Technologies |
| 31 Jul 2007 | K071590 | THERMA-CURE | Reliance Orthodontic Products, Inc. |
| 12 Feb 2007 | K061252 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM | Primus Consulting |
| 6 Jul 2006 | K061481 | GRENGLOO | Sybron Dental Specialties |
| 25 Jan 2006 | K053379 | RELI-ON ONE STEP, ORTHODONTIC ADHESIVE | Classone Orthodontics, Inc. |
| 6 Apr 2005 | K050750 | LC BRACKET ADHESIVE SYSTEM | Dentsply Intl., Inc. |
| 15 Nov 2004 | K042422 | D3 CHROMA | Sybron Dental Specialties |
| 2 Apr 2004 | K040375 | IDEAL 1 ORTHODONTIC BAND CEMENT | Dentsply Intl., Inc. |
| 19 Mar 2004 | K040548 | AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE | Harry J. Bosworth Co. |
| 19 Mar 2004 | K040547 | AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE | Harry J. Bosworth Co. |
| 6 Feb 2004 | K033703 | IDEAL 1 ORTHODONTIC BRACKET ADHESIVE | Dentsply Intl., Inc. |
| 16 Dec 2003 | K033551 | EVOLVE | Reliance Orthodontic Products, Inc. |
| 21 Nov 2003 | K030644 | CONTEC DUO, CONTEC LC, CONTEC LCR | Dentaurum |
| 7 Oct 2003 | K032195 | DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT | Dentaurum |
| 6 Oct 2003 | K032407 | OPTIBAND LC | Sybron Dental Specialties |
| 29 Sep 2003 | K032042 | ENVISION | Sybron Dental Specialties |
| 25 Aug 2003 | K030980 | DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE | Dentaurum |
| 25 Aug 2003 | K030977 | DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE | Dentaurum |
| 20 Aug 2003 | K031420 | S & C -BRACKET ADHESIVES | S & C Polymer GmbH |
| 12 Mar 2003 | K030036 | TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT | Pulpdent Corporation |
| 18 Sep 2002 | K022224 | COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM | Coltene AG |
| 1 May 2002 | K020648 | GRIDLOCK 195 ADHESIVE | Allodex Systems |
| 1 May 2002 | K020502 | SOLO ORTHO 3 | Sybron Dental Specialties |
| 26 Apr 2002 | K020578 | GC FUJI ORTHO BAND PASTE PAK | GC America Inc. |
| 12 Apr 2002 | K020394 | APC PLUS ADHESIVE | 3M Unitek Corporation |
| 14 Mar 2002 | K014138 | PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT | Pulpdent Corporation |
| 14 Mar 2002 | K014133 | PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE | Pulpdent Corporation |
| 28 Feb 2002 | K020115 | PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM | Pulpdent Corporation |
| 28 Feb 2002 | K014142 | UNITE BONDING ADHESIVE | 3M Unitek Corporation |
| 27 Feb 2002 | K014059 | PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE | Pulpdent Corporation |
| 24 Oct 2001 | K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | Prime Dental Manufacturing, Inc. |
| 17 Sep 2001 | K012032 | FIRST SPEP | Bisco, Inc. |
| 10 Aug 2001 | K010544 | VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE | Apex Dental Materials, Inc. |
| 1 Aug 2001 | K011521 | ORTHO VLC; ORTHO VLC CAPSULE | First Scientific Limited |
| 22 Aug 2000 | K001881 | IMPROVED ENLIGHT LV | Sybron Dental Specialties |
| 21 Jul 2000 | K001446 | LIGHT-CURED ORTHODONTIC BAND CEMENT | Scientific Pharmaceuticals |
| 27 Apr 2000 | K001048 | LIGHT BOND (QUICK CURE) | Reliance Orthodontic Products, Inc. |
| 17 Mar 2000 | K994309 | SOLO ORTHO 2 | Sybron Dental Specialties |
| 4 Jun 1999 | K990743 | SOLO ORTHO | Sybron Dental Specialties |
| 5 Apr 1999 | K981036 | SMARTBOND | Gac Intl., Inc. |
| 25 Feb 1999 | K990252 | SOLO PLUS ORTHO | Sybron Dental Specialties |
| 21 Jan 1999 | K984362 | ENLIGHT LV | Sybron Dental Specialties |
| 20 Jan 1999 | K984217 | ENLIGHT-2 | Sybron Dental Specialties |
| 25 Jun 1998 | K981461 | GC FUJI ORTHO LC | GC America Inc. |
| 16 Sep 1997 | K972890 | ENLIGHT (TENTATIVE NAME) | Sybron Dental Specialties |
| 3 Sep 1996 | K962946 | ORTHO-ONE | Bisco, Inc. |
| 24 May 1996 | K961417 | GC FUJI ORTHO | GC America Inc. |
| 28 Mar 1996 | K955329 | RESILIENCE M5 PROTECTION PLUS | Confi-Dental Products Co. |
| 19 Oct 1995 | K954374 | AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM | American Dental Products, Inc. |
| 19 Oct 1995 | K954373 | AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE | American Dental Products, Inc. |
| 17 Oct 1995 | K954372 | AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE | American Dental Products, Inc. |
| 12 Oct 1995 | K954333 | AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM | American Dental Products, Inc. |
| 12 Oct 1995 | K954244 | AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM W/FLUORIDE | American Dental Products, Inc. |
| 12 Sep 1995 | K952856 | LIGHT-CURE PC | Midwest Orthodontic Mfg. |
| 8 Sep 1995 | K952855 | PC-LOCK | Midwest Orthodontic Mfg. |
| 5 Sep 1995 | K952858 | LIGHT-CURE | Midwest Orthodontic Mfg. |
| 5 Sep 1995 | K952857 | PRO-LOCK | Midwest Orthodontic Mfg. |
| 25 Aug 1995 | K953217 | PULPDENT TOUCHDOWN | Pulpdent Corporation |
| 14 Jul 1995 | K952854 | PULPDENT GLASS IONOMER CEMENTS | Pulpdent Corporation |
| 11 Jul 1995 | K952643 | RIGHT-ON ADHESIVE BOUDING SYSTEM | Tp Orthodontics, Inc. |
| 27 Apr 1995 | K951381 | VILA | Health-Dent Intl., Inc. |
| 27 Apr 1995 | K951380 | VILA PC | Health-Dent Intl., Inc. |
| 20 Apr 1995 | K951235 | GIROC | Health-Dent Intl., Inc. |
| 18 Apr 1995 | K951236 | PRO-LOCK | Health-Dent Intl., Inc. |
| 8 Mar 1995 | K950556 | FUJI ORTHO LC | GC America Inc. |
| 7 Mar 1995 | K950514 | TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT | 3M Unitek Corporation |
| 7 Mar 1995 | K950512 | AMERICAN DENTAL PRODUCTS (ADP), FLUORIDE RELEASING GLASS IONOMER BAND CEMENT | American Dental Products, Inc. |
| 27 Jan 1995 | K946255 | THERMASET | Sybron Dental Specialties |
| 29 Aug 1994 | K942742 | ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV | Wallace A. Erickson & Co. |
| 23 Aug 1994 | K942727 | ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE | Wallace A. Erickson & Co. |
| 10 Aug 1994 | K935625 | ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE | Wallace A. Erickson & Co. |
| 31 Mar 1994 | K941015 | ORMCO SYSTEM 1+ (TM) | Sybron Dental Specialties |
| 31 Mar 1994 | K940845 | SYSTEM 1 | Sybron Dental Specialties |
| 21 Jan 1994 | K935714 | CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE | Confi-Dental Products Co. |
| 8 Jul 1993 | K925359 | RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS | Confi-Dental Products Co. |
| 17 Jun 1993 | K930614 | ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYST | Wallace A. Erickson & Co. |
| 23 Dec 1992 | K921283 | ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN | Jeneric/Pentron, Inc. |
| 9 Nov 1992 | K921044 | ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND | Wallace A. Erickson & Co. |
| 27 Oct 1992 | K923399 | CHALLENGE II - PASTE ADHESIVE | Sybron Dental Specialties |
| 5 May 1992 | K921245 | THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II | Sybron Dental Specialties |
| 21 Apr 1992 | K921385 | IMPROVED SEQUENCE LIGHT CURE ADHESIVE | Sybron Dental Specialties |
| 21 Apr 1992 | K920781 | FLASH BOND | Advanced Orthodontics Systems, Inc. |
| 26 Mar 1992 | K920534 | PORCELAIN PRIMER | Confi-Dental Products Co. |
| 26 Mar 1992 | K914317 | ORTHODONTIC BRACKET ADHESIVE RESIN MATERIAL | Confi-Dental Products Co. |
| 17 Jan 1992 | K914727 | SEQUENCE LIGHT CURE ADHESIVE | Sybron Dental Specialties |
| 14 Jan 1992 | K913854 | ORTHO LIGHT CURE | Ortho Source |
| 5 Jul 1991 | K911286 | PULPDENT ORTHODONTIC BRACKET ADHESIVE | Pulpdent Corporation |
| 29 May 1991 | K911271 | ADHESIVE PRECOATED BRACKETS | Unitek Corp. |
| 29 Apr 1991 | K904090 | ORTHODONTIC BONDING ADHESIVE CONTROL | Lancer Orthodontics, Inc. |
| 15 Mar 1991 | K910803 | ENAMEL ETCHING GEL | Gresco Products, Inc. |
| 8 Dec 1989 | K895523 | PHASE II ORTHODONTIC ADHESIVE | Reliance Orthodontic Products, Inc. |
| 7 Dec 1989 | K895522 | LIGHT BOND PASTE W/FLUORIDE | Reliance Orthodontic Products, Inc. |
| 7 Dec 1989 | K895521 | RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE) | Reliance Orthodontic Products, Inc. |
| 27 Oct 1989 | K895163 | FORCE II | American Orthodontics |
| 20 Oct 1989 | K894639 | SKYROCK AND LIGHT SUPERBOND | Dent Zar, Inc. |
| 13 Oct 1989 | K894565 | LIGHT BOND SEALANT WITH FLUORIDE | Reliance Orthodontic Products, Inc. |
| 19 Sep 1989 | K894566 | MAXIMUM CURE SEALANT WITH FLUORIDE | Reliance Orthodontic Products, Inc. |
| 23 Jun 1989 | K893396 | AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM | American Orthodontics |
| 21 Jun 1989 | K893255 | SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE | American Orthodontics |
| 12 Jun 1989 | K893037 | NO-MIX 30 ORTHODONTIC BONDING SYSTEMS | American Orthodontics |
| 18 May 1989 | K891464 | RESILIENCE C2, RESILIENCE L3 & RESILIENCE P4 | Confi-Dental Products Co. |
| 1 May 1989 | K890834 | NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC | Scientific Pharmaceuticals |
| 25 Apr 1989 | K890740 | FRS LITE FLUORIDE RELEASING SEALANT | Sybron Dental Specialties |
| 3 Jan 1989 | K884575 | MAXIBOND | Ortho Source |
| 12 Oct 1988 | K883465 | ORTHO-SEAL | Bisco, Inc. |
| 19 Aug 1988 | K880562 | ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT | Macrochem Corp. |
| 13 Jun 1988 | K880793 | LIGHT BOND | Reliance Orthodontic Products, Inc. |
| 13 Jun 1988 | K880791 | MAXIMUM CURE SEALANT | Reliance Orthodontic Products, Inc. |
| 25 Apr 1988 | K880766 | RELIANCE METAL PRIMER | Reliance Orthodontic Products, Inc. |
| 18 Apr 1988 | K880792 | PLASTIC PRIMER | Reliance Orthodontic Products, Inc. |
| 18 Apr 1988 | K880790 | PORCELAIN PRIMER | Reliance Orthodontic Products, Inc. |
| 31 Mar 1988 | K880393 | TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE | Unitek Corp. |
| 18 Mar 1988 | K874228 | BOND FAST NO MIX ADHESIVE | Advanced Orthodontics Systems, Inc. |
| 29 Feb 1988 | K875142 | PHASE II | Reliance Orthodontic Products, Inc. |
| 26 Feb 1988 | K875144 | EXCEL FAST SET | Reliance Orthodontic Products, Inc. |
| 26 Feb 1988 | K875143 | RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE) | Reliance Orthodontic Products, Inc. |
| 26 Feb 1988 | K875141 | EXCEL REGULAR SET | Reliance Orthodontic Products, Inc. |
| 18 May 1987 | K871591 | ORMCO GEL-ETCH | Scientific Pharmaceuticals |
| 21 Jan 1987 | K863709 | CHALLENGE ORTHODONTIC BONDING ADHESIVE | Sybron Dental Specialties |
| 24 Oct 1986 | K864008 | ACCLAIM* BRACKET ADHESIVE | Johnson & Johnson Professionals, Inc. |
| 2 May 1986 | K861118 | ORTHOJOIN, ORTHODONTIC ADHESIVE | Ortho Source |
| 17 Apr 1986 | K861258 | PERMABAND (ORTHODONTIC ADHESIVE) | Ortho Source |
| 25 Mar 1986 | K860959 | DEPENDABOND | Ortho Source |
| 13 Feb 1986 | K844844 | ESPE NIMETIC-GRIP | Espe GmbH (Us) |
| 26 Nov 1985 | K854050 | EXCEL BRACKET ADHESIVE | Johnson & Johnson Professionals, Inc. |
| 7 Nov 1985 | K853523 | VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE | Dentsply Intl., Inc. |
| 4 Jan 1985 | K844134 | CLEANSE N BOND II | Lee Pharmaceuticals |
| 4 Jan 1985 | K844133 | CLEANSE N BOND I | Lee Pharmaceuticals |
| 18 Oct 1984 | K843527 | ORTHOMITE 111 ADHESIVE | Rocky Mountain Orthodontics, Inc. |
| 27 Sep 1984 | K842448 | BOSWORTH SUPER BOND DENTAL ADHESIVE | Harry J. Bosworth Co. |
| 1 Sep 1983 | K832292 | SOLO-TACH | Dentsply Intl., Inc. |
| 31 Aug 1983 | K832291 | AUTO-TACH | Dentsply Intl., Inc. |
| 31 Aug 1983 | K832112 | NO-MIX 30 ORTHODONTIC BONDING SYSTEM | Scientific Pharmaceuticals |
| 18 Jul 1983 | K831495 | CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO | Scientific Pharmaceuticals |
| 26 Jan 1983 | K823928 | TOOTH CONDITIONER | Dentsply Intl., Inc. |
| 21 Jan 1983 | K823409 | HELIOSIT-ORTHODONTIC | Vivadent (Usa), Inc. |
| 9 Jan 1983 | K823851 | ORTHODAPTIC* BONDING ADHESIVE | Johnson & Johnson Professionals, Inc. |
| 24 Feb 1982 | K820092 | SECURE-ON-TOUCH | Sci-Pharm, Inc. |
| 23 Sep 1981 | K812547 | BEAUBON | Sci-Pharm, Inc. |
| 21 Apr 1981 | K810959 | SECURE | Sci-Pharm, Inc. |
| 21 Apr 1981 | K810715 | SECURE | Sci-Pharm, Inc. |
| 24 Mar 1981 | K810517 | INSTA-BOND | Lee Pharmaceuticals |
| 12 Feb 1981 | K810241 | CRYSTAL-BOND | American Ormco |
| 10 Feb 1981 | K810210 | MAGIC-TOUCH | Sci-Pharm, Inc. |
| 10 Apr 1980 | K800392 | BRACKET BONDING SYSTEM METAL & PLASTIC | American Dental Research |
| 27 Nov 1979 | K792003 | 1 STEP | Betta Dental, Inc. |
| 10 Aug 1979 | K791132 | SCI-PHARM ORTHODONTIC ADHESIVE | Scientific Pharmaceuticals |
| 6 Jul 1979 | K790962 | SEAL & BOND DIRECT BONDING ORTHODONTIC | Scientific Pharmaceuticals |
| 28 Mar 1978 | K780334 | ADHESIVE, BRACKET AND CONDITIONER RESIN | Rocky Mountain Orthodontics, Inc. |
| 17 Jan 1978 | K780028 | ORTHODONTIC. PLASTIC BRACKET PRIMER | 3M Company |
| 3 Jan 1978 | K772126 | TEMP. BRIDGE, POSTERIOR 3-UNIT | Lee Pharmaceuticals |
| 20 Oct 1977 | K771883 | REPLICA ACID-ETCH | Hoyt Laboratories |
| 24 Jun 1977 | K771076 | ORTHODONTIC BRACKET ADHESIVE | Lee Pharmaceuticals |
| 23 Aug 1976 | K760378 | CEMENT, RESIN DENTAL (AUTO-TACH) | L.D. Caulk Co. |
| 23 Aug 1976 | K760376 | CEMENT, RESIN DENTAL (SOLO-TACH) | L.D. Caulk Co. |
Official records: FDA product classification for DYH · 21 CFR 872.3750.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026