Adhesive, Bracket And Tooth Conditioner, Resin
FDA product code DYH · Class II (moderate risk) · 21 CFR 872.3750 · Dental
194510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Reliance Orthodontic Products, Inc. 23
- Sybron Dental Specialties, Inc. 12
- Ormco Corp. 10
- Pulpdent Corp. 9
- American Orthodontics 8
- Dentsply Intl. 8
- Scientific Pharmaceuticals, Inc. 7
- 3M Unitek 6
- Confi-Dental Products Co. 6
- GC America, Inc. 6
- American Dental Products, Inc. 6
- Sci-Pharm, Inc. 5
- Wallace A. Erickson & Co. 5
- Ortho Source 5
- Lee Pharmaceuticals 5
- Midwest Orthodontic Mfg. 4
- Bisco, Inc. 4
- Dentaurum 4
- Ultradent Products, Inc. 4
- Health-Dent Intl., Inc. 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261129 | OrthoFitDYH · Traditional | Spident Co., Ltd. | 07/02/2026SE |
| K261840 | BracePaste Prime PlusDYH · Traditional | American Orthodontics | 06/03/2026SE |
| K250015 | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree AdhesiveDYH · Traditional | Ormco Corporation | 01/03/2025SE |
| K242537 | BracePaste Fluoride SealantDYH · Traditional | American Orthodontics Corp. | 08/27/2024SE |
| K234043 | 3M Transbond Orthodontic AdhesiveDYH · Traditional | 3M Unitek Orthodontic Products | 12/22/2023SE |
| K231817 | AlignerFlow LCDYH · Traditional | Voco GmbH | 12/01/2023SE |
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP…DYH · Traditional | Tp Orthodontics, Inc. | 10/14/2022SE |
| K210115 | FiteBac CC OrthoSealDYH · Traditional | Largent Health, LLC | 07/29/2021SE |
| K202276 | BracePaste Band and Build LCDYH · Traditional | American Orthodontics | 08/14/2020SE |
| K192682 | Orthocem, Ortho BiteDYH · Traditional | Dentscare Ltda | 08/14/2020SE |
| K193388 | GlassLok Kits, GlassLok Powder, GlassLok LiquidDYH · Traditional | Reliance Orthodontic Products, Inc. | 04/27/2020SE |
| K183147 | BrackFixDYH · Traditional | Voco GmbH | 03/01/2019SE |
| K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCPDYH · Traditional | Pulpdent Corporation | 01/17/2018SE |
| K160782 | BracePaste AdhesiveDYH · Traditional | American Orthodontics | 10/14/2016SE |
| K161684 | Quantum LBDYH · Traditional | Reliance Orthodontic Products, Inc. | 10/06/2016SE |
| K150128 | GC Ortho Connect, GC Ortho Etching GelDYH · Traditional | Gc Orthodontics America, Inc. | 07/16/2015SE |
| K143667 | GC KommonBaseDYH · Traditional | Gc Orthodontics America, Inc. | 05/07/2015SE |
| K142886 | DMRC Self-Cure Bracket Adhesive One Step and PrimerDYH · Traditional | Danville Materials, LLC | 03/18/2015SE |
| K142881 | DMRC Dual Cure Orthodontic Band CementDYH · Traditional | Danville Materials, LLC | 02/13/2015SE |
| K142880 | DMRC Light Cure Orthodontic Adhesive SystemDYH · Traditional | Daville Materials, LLC | 02/04/2015SE |
| K123348 | Clear Aligner AdhesiveDYH · Traditional | Reliance Orthodontic Products, Inc. | 02/28/2013SE |
| K120619 | Orthodontic Flowable Bracket AdhesiveDYH · Abbreviated | Novocol, Inc. | 05/21/2012SE |
| K113401 | ORTHO-1(NOT Finalized)DYH · Traditional | Bisco, Inc. | 02/07/2012SE |
| K113197 | Apc Flash-Free AdhesiveDYH · Traditional | 3M Unitek Corporation | 02/02/2012SE |
| K111814 | PadlockDYH · Special | Reliance Orthodontic Products, Inc. | 09/14/2011SE |
| K111696 | Opal Band CementDYH · Traditional | Ultradent Products, Inc. | 09/07/2011SE |
| K101951 | Light Cure RetainerDYH · Traditional | Reliance Orthodontic Products, Inc. | 10/26/2010SE |
| K100536 | Transbond Idb Pre-Mix Chemical Care AdhesiveDYH · Traditional | 3M Unitek | 07/27/2010SE |
| K100301 | Opal Bond FlowDYH · Traditional | Ultradent Products, Inc. | 04/29/2010SE |
| K094006 | Opal Bond MVDYH · Traditional | Ultradent Products, Inc. | 03/23/2010SE |
| K093221 | Pre-Cemented Orthodontic Bracket System Extension IIDYH · Special | Dentsply Intl., Inc. | 10/30/2009SE |
| K090355 | Opal SealDYH · Traditional | Ultradent Products, Inc. | 04/29/2009SE |
| K083051 | Flowtain & Flowtain LVDYH · Traditional | Reliance Orthodontic Products, Inc. | 02/20/2009SE |
| K080445 | Lion Se One Step Orthodontic AdhesiveDYH · Traditional | Classone Orthodontics, Inc. | 07/16/2008SE |
| K080724 | GC OPB-100DYH · Traditional | GC America, Inc. | 06/11/2008SE |
| K081291 | Pre-Cemented Orthodontic Bracket System ExtensionDYH · Special | Dentsply Interntional | 05/22/2008SE |
| K073697 | Transbond Supreme AdhesiveDYH · Traditional | 3M Unitek | 02/15/2008SE |
| K073588 | GC Models OPA-100 and JC-50DYH · Traditional | GC America, Inc. | 02/15/2008SE |
| K072978 | Tender Ortho Bond-Ena Bond-Ena EtchDYH · Traditional | Micerium S.P.A. | 01/17/2008SE |
| K072830 | RM Bond, Model J032DYH · Traditional | Pentron Clinical Technologies | 12/04/2007SE |
| K071590 | Therma-CureDYH · Traditional | Reliance Orthodontic Products, Inc. | 07/31/2007SE |
| K061252 | Pre-Cemented Orthodontic Bracket SystemDYH · Traditional | Primus Consulting | 02/12/2007SE |
| K061481 | GrenglooDYH · Traditional | Ormco Corp. | 07/06/2006SE |
| K053379 | Reli-On One Step, Orthodontic AdhesiveDYH · Traditional | Classone Orthodontics, Inc. | 01/25/2006SE |
| K050750 | LC Bracket Adhesive SystemDYH · Special | Dentsply Intl. | 04/06/2005SE |
| K042422 | D3 ChromaDYH · Traditional | Sybron Dental Specialties, Inc. | 11/15/2004SE |
| K040375 | Ideal 1 Orthodontic Band CementDYH · Traditional | Dentsply Intl. | 04/02/2004SE |
| K040548 | Aegis Ortho Light-Cured Orthodontic AdhesiveDYH · Traditional | Harry J. Bosworth Co. | 03/19/2004SE |
| K040547 | Aegis Ortho Dual-Cured Orthodontic AdhesiveDYH · Traditional | Harry J. Bosworth Co. | 03/19/2004SE |
| K033703 | Ideal 1 Orthodontic Bracket AdhesiveDYH · Traditional | Dentsply Intl. | 02/06/2004SE |
| K033551 | EvolveDYH · Special | Reliance Orthodontic Products, Inc. | 12/16/2003SE |
| K030644 | Contec Duo, Contec LC, Contec LCRDYH · Traditional | Dentaurum | 11/21/2003SE |
| K032195 | Dentaurum Glastec Dental Orthodontic CementDYH · Traditional | Dentaurum | 10/07/2003SE |
| K032407 | Optiband LCDYH · Traditional | Sybron Dental Specialties, Inc. | 10/06/2003SE |
| K032042 | EnvisionDYH · Traditional | Sybron Dental Specialties, Inc. | 09/29/2003SE |
| K030980 | Dentaurum No-Mix One Step Bracket AdhesiveDYH · Traditional | Dentaurum | 08/25/2003SE |
| K030977 | Dentaurum Mix Two-Paste Bracket AdhesiveDYH · Traditional | Dentaurum | 08/25/2003SE |
| K031420 | S & C -Bracket AdhesivesDYH · Traditional | S & C Polymer GmbH | 08/20/2003SE |
| K030036 | Triple-Cure Paste/Paste Resin-Reinforced Glass Ionomer CementDYH · Traditional | Pulpdent Corporation | 03/12/2003SE |
| K022224 | Cool Bond Light Cured Bracket Adhesive SystemDYH · Traditional | Coltene AG | 09/18/2002SE |
| K020648 | Gridlock 195 AdhesiveDYH · Traditional | Allodex Systems | 05/01/2002SE |
| K020502 | Solo Ortho 3DYH · Traditional | Sybron Dental Specialties, Inc. | 05/01/2002SE |
| K020578 | GC Fuji Ortho Band Paste PakDYH · Traditional | GC America, Inc. | 04/26/2002SE |
| K020394 | Apc Plus AdhesiveDYH · Traditional | 3M Unitek | 04/12/2002SE |
| K014138 | Pulpdent Triple-Cure Reinforced Glass Ionomer Orthodontic CementDYH · Traditional | Pulpdent Corp. | 03/14/2002SE |
| K014133 | Pulpdent No-Mix Orthodontic Bracket AdhesiveDYH · Traditional | Pulpdent Corp. | 03/14/2002SE |
| K020115 | Pulpdent Sealant/Paste Orthodontic Bracket Adhesive SystemDYH · Traditional | Pulpdent Corp. | 02/28/2002SE |
| K014142 | Unite Bonding AdhesiveDYH · Traditional | 3M Unitek | 02/28/2002SE |
| K014059 | Pulpdent Trans Oba Orthodontic Bracket AdhesiveDYH · Traditional | Pulpdent Corp. | 02/27/2002SE |
| K012673 | Prime-Dent One-Step Orthodontic Adhesive Bonding SystemDYH · Traditional | Prime Dental Manufacturing, Inc. | 10/24/2001SE |
| K012032 | First SpepDYH · Traditional | Bisco, Inc. | 09/17/2001SE |
| K010544 | Vertex L/C Orthodontic Direct Bonding PasteDYH · Traditional | Apex Dental Materials, Inc. | 08/10/2001SE |
| K011521 | Ortho VLC; Ortho VLC CapsuleDYH · Traditional | First Scientific Limited | 08/01/2001SE |
| K001881 | Improved Enlight LVDYH · Traditional | Sybron Dental Specialties, Inc. | 08/22/2000SE |
| K001446 | Light-Cured Orthodontic Band CementDYH · Traditional | Scientific Pharmaceuticals, Inc. | 07/21/2000SE |
| K001048 | Light Bond (Quick Cure)DYH · Traditional | Reliance Orthodontic Products, Inc. | 04/27/2000SE |
| K994309 | Solo Ortho 2DYH · Traditional | Sybron Dental Specialties, Inc. | 03/17/2000SE |
| K990743 | Solo OrthoDYH · Traditional | Sybron Dental Specialties, Inc. | 06/04/1999SE |
| K981036 | SmartbondDYH · Traditional | Gac Intl., Inc. | 04/05/1999SE |
| K990252 | Solo Plus OrthoDYH · Traditional | Sybron Dental Specialties, Inc. | 02/25/1999SE |
| K984362 | Enlight LVDYH · Traditional | Sybron Dental Specialties, Inc. | 01/21/1999SE |
| K984217 | ENLIGHT-2DYH · Traditional | Sybron Dental Specialties, Inc. | 01/20/1999SE |
| K981461 | GC Fuji Ortho LCDYH · Traditional | GC America, Inc. | 06/25/1998SE |
| K972890 | Enlight (Tentative Name)DYH · Traditional | Sybron Dental Specialties, Inc. | 09/16/1997SE |
| K962946 | Ortho-OneDYH · Traditional | Bisco, Inc. | 09/03/1996SE |
| K961417 | GC Fuji OrthoDYH · Traditional | GC America, Inc. | 05/24/1996SE |
| K955329 | Resilience M5 Protection PlusDYH · Traditional | Confi-Dental Products Co. | 03/28/1996SE |
| K954374 | American Dental Products Orthodontic Adhesive, Two Paste Bonding SystemDYH · Traditional | American Dental Products, Inc. | 10/19/1995SE |
| K954373 | American Dental Products Paste-Primer Adhesive Orthodontic Bonding System W/FluorideDYH · Traditional | American Dental Products, Inc. | 10/19/1995SE |
| K954372 | American Dental Products Two Paste Adhesive Orthodontic Bonding System W/FluorideDYH · Traditional | American Dental Products, Inc. | 10/17/1995SE |
| K954333 | American Dental Products Orthodontic Adhesive W/One Step Bonding SystemDYH · Traditional | American Dental Products, Inc. | 10/12/1995SE |
| K954244 | American Dental Products Light Activated Orthodontic Adhesive Bonding System W/FluorideDYH · Traditional | American Dental Products, Inc. | 10/12/1995SE |
| K952856 | Light-Cure PCDYH · Traditional | Midwest Orthodontic Mfg. | 09/12/1995SE |
| K952855 | Pc-LockDYH · Traditional | Midwest Orthodontic Mfg. | 09/08/1995SE |
| K952858 | Light-CureDYH · Traditional | Midwest Orthodontic Mfg. | 09/05/1995SE |
| K952857 | Pro-LockDYH · Traditional | Midwest Orthodontic Mfg. | 09/05/1995SE |
| K953217 | Pulpdent TouchdownDYH · Traditional | Pulpdent Corp. | 08/25/1995SE |
| K952854 | Pulpdent Glass Ionomer CementsDYH · Traditional | Pulpdent Corp. | 07/14/1995SE |
| K952643 | Right-On Adhesive Bouding SystemDYH · Traditional | Tp Orthodontics, Inc. | 07/11/1995SE |
| K951381 | VilaDYH · Traditional | Health-Dent Intl., Inc. | 04/27/1995SE |
| K951380 | Vila PCDYH · Traditional | Health-Dent Intl., Inc. | 04/27/1995SE |
| K951235 | GirocDYH · Traditional | Health-Dent Intl., Inc. | 04/20/1995SE |
| K951236 | Pro-LockDYH · Traditional | Health-Dent Intl., Inc. | 04/18/1995SE |
| K950556 | Fuji Ortho LCDYH · Traditional | GC America, Inc. | 03/08/1995SE |
| K950514 | Tri-Cure Glass Ionomer Orthodontic Band CementDYH · Traditional | 3M Unitek | 03/07/1995SE |
| K950512 | American Dental Products (Adp), Fluoride Releasing Glass Ionomer Band CementDYH · Traditional | American Dental Products, Inc. | 03/07/1995SE |
| K946255 | ThermasetDYH · Traditional | Ormco Corp. | 01/27/1995SE |
| K942742 | Alpha Bond-Rite Ii(Tm) or Bond-Rite Ii(Tm) 2-PASTE AdhevDYH · Traditional | Wallace A. Erickson & Co. | 08/29/1994SE |
| K942727 | Alpha Bound-Rite I No-Mix Adhesive or Bond-Rite I No-Mix AdhesiveDYH · Traditional | Wallace A. Erickson & Co. | 08/23/1994SE |
| K935625 | Alphadent Light Activated Orthodontic Adhesive Bonding System with FluorideDYH · Traditional | Wallace A. Erickson & Co. | 08/10/1994SE |
| K941015 | Ormco System 1+ (TM)DYH · Traditional | Ormco Corp. | 03/31/1994SE |
| K940845 | System 1DYH · Traditional | Sybron Dental Specialties, Inc. | 03/31/1994SE |
| K935714 | Crystalline L3 Multi-Use Hybrid CompositeDYH · Traditional | Confi-Dental Products Co. | 01/21/1994SE |
| K925359 | Resilience Orthodontic Bracket Adhes W/Bond ResinsDYH · Traditional | Confi-Dental Products Co. | 07/08/1993SE |
| K930614 | Alpha-Dent Orthodontic Adhes Two-Paste Bond SystDYH · Traditional | Wallace A. Erickson & Co. | 06/17/1993SE |
| K921283 | Adhesive, Bracket and Tooth Conditioner ResinDYH · Traditional | Jeneric/Pentron, Inc. | 12/23/1992SE |
| K921044 | Alpha-Dent Orthodontic Adhesive with One Step BondDYH · Traditional | Wallace A. Erickson & Co. | 11/09/1992SE |
| K923399 | Challenge II - Paste AdhesiveDYH · Traditional | Ormco Corp. | 10/27/1992SE |
| K921245 | The Bracket Assembly W/ Security System IIDYH · Traditional | Ormco Corp. | 05/05/1992SE |
| K921385 | Improved Sequence Light Cure AdhesiveDYH · Traditional | Ormco Corp. | 04/21/1992SE |
| K920781 | Flash BondDYH · Traditional | Advanced Orthodontics Systems, Inc. | 04/21/1992SE |
| K920534 | Porcelain PrimerDYH · Traditional | Confi-Dental Products Co. | 03/26/1992SE |
| K914317 | Orthodontic Bracket Adhesive Resin MaterialDYH · Traditional | Confi-Dental Products Co. | 03/26/1992SE |
| K914727 | Sequence Light Cure AdhesiveDYH · Traditional | Ormco Corp. | 01/17/1992SE |
| K913854 | Ortho Light CureDYH · Traditional | Ortho Source | 01/14/1992SE |
| K911286 | Pulpdent Orthodontic Bracket AdhesiveDYH · Traditional | Pulpdent Corp. | 07/05/1991SE |
| K911271 | Adhesive Precoated BracketsDYH · Traditional | Unitek Corp. | 05/29/1991SE |
| K904090 | Orthodontic Bonding Adhesive ControlDYH · Traditional | Lancer Orthodontics, Inc. | 04/29/1991SE |
| K910803 | Enamel Etching GelDYH · Traditional | Gresco Products, Inc. | 03/15/1991SE |
| K895523 | Phase II Orthodontic AdhesiveDYH · Traditional | Reliance Orthodontic Products, Inc. | 12/08/1989SE |
| K895522 | Light Bond Paste W/FluorideDYH · Traditional | Reliance Orthodontic Products, Inc. | 12/07/1989SE |
| K895521 | Rely-A-Bond W/Fluoride (No Mix Adhesive)DYH · Traditional | Reliance Orthodontic Products, Inc. | 12/07/1989SE |
| K895163 | Force IIDYH · Traditional | American Orthodontics | 10/27/1989SE |
| K894639 | Skyrock and Light SuperbondDYH · Traditional | Dent Zar, Inc. | 10/20/1989SE |
| K894565 | Light Bond Sealant with FluorideDYH · Traditional | Reliance Orthodontic Products, Inc. | 10/13/1989SE |
| K894566 | Maximum Cure Sealant with FluorideDYH · Traditional | Reliance Orthodontic Products, Inc. | 09/19/1989SE |
| K893396 | An Alternative Direct Bonding Ortho. SystemDYH · Traditional | American Orthodontics | 06/23/1989SE |
| K893255 | Spectrum, Visible Light Cure Orthodontic AdhesiveDYH · Traditional | American Orthodontics | 06/21/1989SE |
| K893037 | No-Mix 30 Orthodontic Bonding SystemsDYH · Traditional | American Orthodontics | 06/12/1989SE |
| K891464 | Resilience C2, Resilience L3 & Resilience P4DYH · Traditional | Confi-Dental Products Co. | 05/18/1989SE |
| K890834 | No-Mix 30 Orthodontic Bonding System, PlasticDYH · Traditional | Scientific Pharmaceuticals, Inc. | 05/01/1989SE |
| K890740 | FRS Lite Fluoride Releasing SealantDYH · Traditional | Ormco Corp. | 04/25/1989SE |
| K884575 | MaxibondDYH · Traditional | Ortho Source | 01/03/1989SE |
| K883465 | Ortho-SealDYH · Traditional | Bisco, Inc. | 10/12/1988SE |
| K880562 | Additional Claims to Dental Restorative Comp. KitDYH · Traditional | Macrochem Corp. | 08/19/1988SN |
| K880793 | Light BondDYH · Traditional | Reliance Orthodontic Products, Inc. | 06/13/1988SE |
| K880791 | Maximum Cure SealantDYH · Traditional | Reliance Orthodontic Products, Inc. | 06/13/1988SE |
| K880766 | Reliance Metal PrimerDYH · Traditional | Reliance Orthodontic Products, Inc. | 04/25/1988SE |
| K880792 | Plastic PrimerDYH · Traditional | Reliance Orthodontic Products, Inc. | 04/18/1988SE |
| K880790 | Porcelain PrimerDYH · Traditional | Reliance Orthodontic Products, Inc. | 04/18/1988SE |
| K880393 | Transbond Light Cured Orthodontic AdhesiveDYH · Traditional | Unitek Corp. | 03/31/1988SE |
| K874228 | Bond Fast No Mix AdhesiveDYH · Traditional | Advanced Orthodontics Systems, Inc. | 03/18/1988SE |
| K875142 | Phase IIDYH · Traditional | Reliance Orthodontic Products, Inc. | 02/29/1988SE |
| K875144 | Excel Fast SetDYH · Traditional | Reliance Orthodontic Products, Inc. | 02/26/1988SE |
| K875143 | Rely-A-Bond(No Mix Orthodontic Adhesive)DYH · Traditional | Reliance Orthodontic Products, Inc. | 02/26/1988SE |
| K875141 | Excel Regular SetDYH · Traditional | Reliance Orthodontic Products, Inc. | 02/26/1988SE |
| K871591 | Ormco Gel-EtchDYH · Traditional | Scientific Pharmaceuticals, Inc. | 05/18/1987SE |
| K863709 | Challenge Orthodontic Bonding AdhesiveDYH · Traditional | Ormco Corp. | 01/21/1987SE |
| K864008 | Acclaim* Bracket AdhesiveDYH · Traditional | Johnson & Johnson Professionals, Inc. | 10/24/1986SE |
| K861118 | Orthojoin, Orthodontic AdhesiveDYH · Traditional | Ortho Source | 05/02/1986SE |
| K861258 | Permaband (Orthodontic Adhesive)DYH · Traditional | Ortho Source | 04/17/1986SE |
| K860959 | DependabondDYH · Traditional | Ortho Source | 03/25/1986SE |
| K844844 | Espe Nimetic-GripDYH · Traditional | Espe GmbH (Us) | 02/13/1986SE |
| K854050 | Excel Bracket AdhesiveDYH · Traditional | Johnson & Johnson Professionals, Inc. | 11/26/1985SE |
| K853523 | Visible Light Cured Orthodontic AdhesiveDYH · Traditional | Dentsply Intl. | 11/07/1985SE |
| K844134 | Cleanse N Bond IIDYH · Traditional | Lee Pharmaceuticals | 01/04/1985SE |
| K844133 | Cleanse N Bond IDYH · Traditional | Lee Pharmaceuticals | 01/04/1985SE |
| K843527 | Orthomite 111 AdhesiveDYH · Traditional | Rocky Mountain Orthodontics, Inc. | 10/18/1984SE |
| K842448 | Bosworth Super Bond Dental AdhesiveDYH · Traditional | Harry J. Bosworth Co. | 09/27/1984SE |
| K832292 | Solo-TachDYH · Traditional | Dentsply Intl. | 09/01/1983SE |
| K832291 | Auto-TachDYH · Traditional | Dentsply Intl. | 08/31/1983SE |
| K832112 | No-Mix 30 Orthodontic Bonding SystemDYH · Traditional | Scientific Pharmaceuticals, Inc. | 08/31/1983SE |
| K831495 | Curay-Eclipse Visible Light Cured OrthoDYH · Traditional | Scientific Pharmaceuticals, Inc. | 07/18/1983SE |
| K823928 | Tooth ConditionerDYH · Traditional | Dentsply Intl. | 01/26/1983SE |
| K823409 | Heliosit-OrthodonticDYH · Traditional | Vivadent (Usa), Inc. | 01/21/1983SE |
| K823851 | Orthodaptic* Bonding AdhesiveDYH · Traditional | Johnson & Johnson Professionals, Inc. | 01/09/1983SE |
| K820092 | Secure-On-TouchDYH · Traditional | Sci-Pharm, Inc. | 02/24/1982SE |
| K812547 | BeaubonDYH · Traditional | Sci-Pharm, Inc. | 09/23/1981SE |
| K810959 | SecureDYH · Traditional | Sci-Pharm, Inc. | 04/21/1981SE |
| K810715 | SecureDYH · Traditional | Sci-Pharm, Inc. | 04/21/1981SE |
| K810517 | Insta-BondDYH · Traditional | Lee Pharmaceuticals | 03/24/1981SE |
| K810241 | Crystal-BondDYH · Traditional | American Ormco | 02/12/1981SE |
| K810210 | Magic-TouchDYH · Traditional | Sci-Pharm, Inc. | 02/10/1981SE |
| K800392 | Bracket Bonding System Metal & PlasticDYH · Traditional | American Dental Research | 04/10/1980SE |
| K792003 | 1 StepDYH · Traditional | Betta Dental, Inc. | 11/27/1979SE |
| K791132 | Sci-Pharm Orthodontic AdhesiveDYH · Traditional | Scientific Pharmaceuticals, Inc. | 08/10/1979SE |
| K790962 | Seal & Bond Direct Bonding OrthodonticDYH · Traditional | Scientific Pharmaceuticals, Inc. | 07/06/1979SE |
| K780334 | Adhesive, Bracket and Conditioner ResinDYH · Traditional | Rocky Mountain Orthodontics, Inc. | 03/28/1978SE |
| K780028 | Orthodontic. Plastic Bracket PrimerDYH · Traditional | 3M Company | 01/17/1978SE |
| K772126 | Temp. Bridge, Posterior 3-UNITDYH · Traditional | Lee Pharmaceuticals | 01/03/1978SE |
| K771883 | Replica Acid-EtchDYH · Traditional | Hoyt Laboratories | 10/20/1977SE |
| K771076 | Orthodontic Bracket AdhesiveDYH · Traditional | Lee Pharmaceuticals | 06/24/1977SE |
| K760378 | Cement, Resin Dental (Auto-Tach)DYH · Traditional | L.D. Caulk Co. | 08/23/1976SE |
| K760376 | Cement, Resin Dental (Solo-Tach)DYH · Traditional | L.D. Caulk Co. | 08/23/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0916-2008 | Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322…Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of… | Ormco Corporation | 10/31/2007Terminated |