Product code DYH
- Device name
- Adhesive, Bracket And Tooth Conditioner, Resin
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3750
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250015 | Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive | Ormco Corporation | 2025-01-03 |
| K242537 | BracePaste Fluoride Sealant | American Orthodontics Corp. | 2024-08-27 |
| K234043 | 3M™ Transbond™ Orthodontic Adhesive | 3M Unitek Orthodontic Products | 2023-12-22 |
| K231817 | AlignerFlow LC | Voco GmbH | 2023-12-01 |
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 | Tp Orthodontics, Inc. | 2022-10-14 |
| K210115 | FiteBac CC OrthoSeal | Largent Health, LLC | 2021-07-29 |
| K202276 | BracePaste Band and Build LC | American Orthodontics | 2020-08-14 |
| K192682 | Orthocem, Ortho Bite | Dentscare Ltda | 2020-08-14 |
| K193388 | GlassLok Kits, GlassLok Powder, GlassLok Liquid | Reliance Orthodontic Products, Inc. | 2020-04-27 |
| K183147 | BrackFix | Voco GmbH | 2019-03-01 |
| K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCP | Pulpdent Corporation | 2018-01-17 |
| K160782 | BracePaste Adhesive | American Orthodontics | 2016-10-14 |
| K161684 | Quantum LB | Reliance Orthodontic Products, Inc. | 2016-10-06 |
| K150128 | GC Ortho Connect, GC Ortho Etching Gel | Gc Orthodontics America, Inc. | 2015-07-16 |
| K143667 | GC KommonBase | Gc Orthodontics America, Inc. | 2015-05-07 |
| K142886 | DMRC Self-Cure Bracket Adhesive One Step and Primer | Danville Materials, LLC | 2015-03-18 |
| K142881 | DMRC Dual Cure Orthodontic Band Cement | Danville Materials, LLC | 2015-02-13 |
| K142880 | DMRC Light Cure Orthodontic Adhesive System | Daville Materials, LLC | 2015-02-04 |
| K123348 | CLEAR ALIGNER ADHESIVE | Reliance Orthodontic Products, Inc. | 2013-02-28 |
| K120619 | ORTHODONTIC FLOWABLE BRACKET ADHESIVE | Novocol, Inc. | 2012-05-21 |
| K113401 | ORTHO-1(NOT FINALIZED) | Bisco, Inc. | 2012-02-07 |
| K113197 | APC FLASH-FREE ADHESIVE | 3M Unitek Corporation | 2012-02-02 |
| K111814 | PADLOCK | Reliance Orthodontic Products, Inc. | 2011-09-14 |
| K111696 | OPAL BAND CEMENT | Ultradent Products, Inc. | 2011-09-07 |
| K101951 | LIGHT CURE RETAINER | Reliance Orthodontic Products, Inc. | 2010-10-26 |
| K100536 | TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE | 3M Unitek | 2010-07-27 |
| K100301 | OPAL BOND FLOW | Ultradent Products, Inc. | 2010-04-29 |
| K094006 | OPAL BOND MV | Ultradent Products, Inc. | 2010-03-23 |
| K093221 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II | Dentsply Intl., Inc. | 2009-10-30 |
| K090355 | OPAL SEAL | Ultradent Products, Inc. | 2009-04-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10386040008655 | GC Fuji ORTHO™ | Gc America Inc. | 2022-07-13 |
| 10386040009683 | GC Fuji ORTHO™ | Gc America Inc. | 2022-07-13 |
| 10386040009690 | GC Fuji ORTHO™ | Gc America Inc. | 2022-07-13 |
| 10386040009867 | GC Fuji ORTHO™ | Gc America Inc. | 2022-07-13 |
| 10386040009805 | GC Fuji ORTHO™ | Gc America Inc. | 2022-07-13 |
| 10386040009799 | GC Fuji ORTHO™ | Gc America Inc. | 2022-07-13 |
| 07899633815982 | Ortho Bite | Dentscare Ltda | 2022-04-27 |
| EMICCPCK1 | EnaCem HF | MICERIUM SPA | 2021-12-02 |
| 07899633828463 | Suppra O-Cem Plus | Dentscare Ltda | 2021-11-01 |
| 07899633826582 | Orthocem | Dentscare Ltda | 2020-10-30 |
| J0111631200000 | N.A. | DENTAURUM GmbH & Co.KG | 2018-10-23 |
| EMICCOSM300A0 | Ena Bond ® | MICERIUM SPA | 2017-11-08 |
| 10190886010730 | OCS ETCH GEL SYRINGE | G & H Wire Company, Inc. | 2017-01-06 |
| 10190886000670 | BONDPRO™ LIGHT ACTIVATED ADHES 5gm SYRINGE | G & H Wire Company, Inc. | 2016-09-24 |
| 10190886000731 | BONDPRO™ ETCHANT GEL 1-12g KIT | G & H Wire Company, Inc. | 2016-09-24 |
| 10190886000717 | BONDPRO™ AUTOMIX DUAL CURE BAND CEMENT 10gm SYRINGE | G & H Wire Company, Inc. | 2016-09-24 |
| 10190886000700 | BONDPRO™ AUTOMIX DUAL CURE BAND CEMENT KIT | G & H Wire Company, Inc. | 2016-09-24 |
| 10190886000694 | BONDPRO™ AUTOMIX DUAL CURE BAND CEMENT INTRO KIT | G & H Wire Company, Inc. | 2016-09-24 |
| 10190886000687 | BONDPRO™ LIGHT ACTIVATED RESIN 7ml | G & H Wire Company, Inc. | 2016-09-24 |
| 10190886000663 | BONDPRO™ LIGHT ACTIVATED ADHESIVE 4-5gm SYRINGES | G & H Wire Company, Inc. | 2016-09-24 |
| 10190886000656 | BONDPRO™ LIGHT ACTIVATED ADHES 1-5gm SYRINGE KIT | G & H Wire Company, Inc. | 2016-09-24 |
| 10190886000649 | BONDPRO™ GLASS IONOMER CEMENT POWDER/LIQUID KIT | G & H Wire Company, Inc. | 2016-09-24 |
| 10190886000632 | BONDPRO™ LIQUID ETCHANT 7ml | G & H Wire Company, Inc. | 2016-09-24 |
| 10190886000625 | BONDPRO™ ONE STEP ADHESIVE SYR 5gm | G & H Wire Company, Inc. | 2016-09-24 |
| 10190886000618 | BONDPRO™ ONE STEP ADHESIVE KIT 4-5gm SYRINGES | G & H Wire Company, Inc. | 2016-09-24 |
| 10190886000601 | BONDPRO™ ONE STEP ADHESIVE KIT 1-5gm SYRINGE | G & H Wire Company, Inc. | 2016-09-24 |
| 10190886000564 | OCS GREEN 37% ETCH LIQUID 2OZ | G & H Wire Company, Inc. | 2016-09-24 |
| 10190886000557 | OCS GREEN 37% ETCH GEL 2OZ | G & H Wire Company, Inc. | 2016-09-24 |
| 10190886000519 | 12 GM ETCH GEL WITH 25 TIPS | G & H Wire Company, Inc. | 2016-09-24 |
| 10817713020075 | ORAPRO | ORTHOQUEST, INC. | 2016-09-20 |