Coating, Filling Material, Resin
FDA product code EBD · Class II (moderate risk) · 21 CFR 872.3310 · Dental
52510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Bisco, Inc. 6
- Scientific Pharmaceuticals, Inc. 4
- 3M Company 3
- Cosmedent, Inc. 3
- Parkell, Inc. 2
- Kerr Dental Materials Center 2
- GC America, Inc. 2
- Dentsply Intl. 2
- Lever Brothers Company, Inc. 1
- Foremost Dental Mfg., Inc. 1
- YAMAHACHI DENTAL MFG., Co. 1
- Pulpdent Corp. 1
- Austenal Dental, Inc. 1
- Espe GmbH (Us) 1
- Lee Pharmaceuticals 1
- Johnson & Johnson Professionals, Inc. 1
- Sybron Corp. 1
- Howmedica Corp. 1
- Dental-Material Gesellschaft 1
- Vivadent (Usa), Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254091 | Glossy Coat (15ML)EBD · Traditional | YAMAHACHI DENTAL MFG., Co. | 04/06/2026SE |
| K250804 | Id Light Cure SystemEBD · Traditional | Id Korea Co., Ltd. | 06/04/2025SE |
| K240735 | visio.lign color, visio.lign shieldEBD · Traditional | Bredent GmbH & Co. KG | 12/12/2024SE |
| K223365 | RODIN Palette Naturalizing KitEBD · Traditional | Belport Company, Inc., Gingi-Pak | 03/27/2023SE |
| K211854 | VITA Akzent LCEBD · Traditional | Vita Zahnfabrik GmbH H Rauter & CO | 11/22/2021SE |
| K162408 | Nano Varnish, Plaquit, Lightpaint on SurfaceEBD · Traditional | Dreve Dentamid GmbH | 04/05/2018SE |
| K163568 | Shofu Resin GlazeEBD · Traditional | Shofu Dental Corporation | 08/16/2017SE |
| K133836 | Optiglaze ColorEBD · Traditional | GC America, Inc. | 03/06/2014SE |
| K123761 | Vita Enamic StainsEBD · Traditional | Innovation Meditech GmbH | 03/01/2013SE |
| K093019 | Enamelite Acryseal Spray SealantEBD · Traditional | Enamelite, LLC | 12/22/2009SE |
| K082285 | Easy GlazeEBD · Traditional | Voco GmbH | 10/24/2008SE |
| K080549 | Durafinish All-Cure, Model S296EBD · Traditional | Parkell, Inc. | 05/13/2008SE |
| K073243 | LED Pro SealEBD · Traditional | Reliance Orthodontic Products, Inc. | 02/08/2008SE |
| K070306 | Paint- on Polish AgentEBD · Traditional | Dentsply International, Inc. | 03/22/2007SE |
| K063228 | Surface CoatEBD · Traditional | Kuraray America, Inc. | 12/08/2006SE |
| K052462 | G-CoatEBD · Traditional | GC America, Inc. | 10/20/2005SE |
| K051999 | Biscover LEDEBD · Traditional | Bisco, Inc. | 08/22/2005SE |
| K043168 | Biscover LVEBD · Traditional | Bisco, Inc. | 02/01/2005SE |
| K040599 | Parkell Resin GlazeEBD · Traditional | Parkell, Inc. | 04/09/2004SE |
| K030646 | Belleglass Point 4EBD · Traditional | Kerr Dental Materials Center | 05/06/2003SE |
| K030585 | Sculpting ResinEBD · Traditional | Bisco, Inc. | 04/28/2003SE |
| K030354 | Biscover Liquid Polish Kit, Biscover Liquid Polish and Biscover Viscosity ModifierEBD · Special | Bisco, Inc. | 02/19/2003SE |
| K024046 | Tescera Glazing Resin, Model T-1804, Biscover XT, Model G-93220PEBD · Traditional | Bisco, Inc. | 02/06/2003SE |
| K021503 | UninhibitedEBD · Traditional | Bisco, Inc. | 08/01/2002SE |
| K011239 | Ginda GuardEBD · Traditional | Cosmedent, Inc. | 02/14/2002SE |
| K013179 | LuxaglazeEBD · Traditional | Dmg USA, Inc. | 10/12/2001SE |
| K992067 | BelleglazeEBD · Traditional | Kerr Dental Materials Center | 08/27/1999SE |
| K984037 | Core-IdeEBD · Traditional | Roydent Dental Products, Inc. | 02/04/1999SE |
| K980298 | Flowable HybridEBD · Traditional | Cosmedent, Inc. | 03/09/1998SE |
| K974494 | Renamel Flowable CompositeEBD · Traditional | Cosmedent, Inc. | 02/10/1998SE |
| K935689 | Ionosit Base LinerEBD · Traditional | Foremost Dental Mfg., Co. | 01/21/1994SE |
| K904135 | Foundation Hybrid CompositeEBD · Traditional | Nulite Systems Research | 05/15/1991SE |
| K901050 | No-Stick Composite Instrument DipEBD · Traditional | Pulpdent Corp. | 04/19/1990SE |
| K862590 | 3M Esthetic Design System (Tints & Masking Agents)EBD · Traditional | 3M Company | 07/22/1986SE |
| K854957 | Austenal Dental Composite ResinEBD · Traditional | Austenal Dental, Inc. | 01/30/1986SE |
| K844845 | Espe Ketac-BondEBD · Traditional | Espe GmbH (Us) | 08/19/1985SE |
| K850610 | Pepsodent Denture Adhesive CreamEBD · Traditional | Lever Brothers Company, Inc. | 05/15/1985SE |
| K850675 | Curay Join Dent Dentin PrimerEBD · Traditional | Scientific Pharmaceuticals, Inc. | 03/25/1985SE |
| K850641 | Caulk Dycal Light CuredEBD · Traditional | Dentsply Intl. | 03/18/1985SE |
| K850073 | J & J Light Curing Dentin/Enamel Bonding AgentEBD · Traditional | Johnson & Johnson Professionals, Inc. | 02/08/1985SE |
| K840751 | Opaque Coating & Surface StainEBD · Traditional | Dentsply Intl. | 05/11/1984SE |
| K832834 | Concise 2 Small Particle Light CurvedEBD · Traditional | 3M Company | 09/29/1983SE |
| K823732 | CBM, Core Build-Up MaterialEBD · Traditional | Scientific Pharmaceuticals, Inc. | 12/28/1982SE |
| K822869 | Command Bonding Resin/Glaze/OpaquerEBD · Traditional | Sybron Corp. | 10/13/1982SE |
| K822714 | Conclude Composite Luting CementEBD · Traditional | 3M Company | 09/28/1982SE |
| K813328 | Myerson/Kenson GP PolymerEBD · Traditional | Howmedica Corp. | 02/24/1982SE |
| K810813 | Dmg-Polishable CompositeEBD · Traditional | Dental-Material Gesellschaft | 04/14/1981SE |
| K791078 | Anterior/Posterior Restorative, BondEBD · Traditional | Scientific Pharmaceuticals, Inc. | 08/10/1979SE |
| K791067 | Sci-Pharm Paint-On RestorativeEBD · Traditional | Scientific Pharmaceuticals, Inc. | 08/10/1979SE |
| K790438 | ColorantEBD · Traditional | Vivadent (Usa), Inc. | 04/10/1979SE |
| K781345 | Ultrafill- UltraboundEBD · Traditional | Demetron Research Corp. | 08/31/1978SE |
| K760419 | Adhesion PromotorEBD · Traditional | Lee Pharmaceuticals | 08/23/1976SE |