Coating, Filling Material, Resin
Regulation 872.3310
1510(k)s in 12 months (52 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in EBD
| Company | 510(k)s | Recalls |
|---|---|---|
| Bisco, Inc. | 6 | 0 |
| Scientific Pharmaceuticals, Inc. | 4 | 0 |
| 3M Company | 3 | 0 |
| Cosmedent, Inc. | 3 | 0 |
| Dentsply Intl. | 2 | 0 |
| GC America, Inc. | 2 | 0 |
| Kerr Dental Materials Center | 2 | 0 |
| Parkell, Inc. | 2 | 0 |
| Austenal Dental, Inc. | 1 | 0 |
| Belport Company, Inc., Gingi-Pak | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 6, 2026 | K254091 | GLOSSY COAT (15ML) YAMAHACHI DENTAL MFG., Co., JP | EBD |
| Jun 4, 2025 | K250804 | ID LIGHT CURE SYSTEM Id Korea Co., Ltd., KR | EBD |
| Dec 12, 2024 | K240735 | visio.lign color, visio.lign shield Bredent GmbH & Co. KG, DE | EBD |
| Mar 27, 2023 | K223365 | RODIN Palette Naturalizing Kit Belport Company, Inc., Gingi-Pak | EBD |
| Nov 22, 2021 | K211854 | VITA Akzent LC Vita Zahnfabrik GmbH H Rauter & CO, DE | EBD |
| Apr 5, 2018 | K162408 | Nano Varnish, Plaquit, Lightpaint on Surface Dreve Dentamid GmbH, DE | EBD |
| Aug 16, 2017 | K163568 | SHOFU RESIN GLAZE Shofu Dental Corporation | EBD |
| Mar 6, 2014 | K133836 | OPTIGLAZE COLOR GC America, Inc. | EBD |
| Mar 1, 2013 | K123761 | VITA ENAMIC STAINS Innovation Meditech GmbH | EBD |
| Dec 22, 2009 | K093019 | ENAMELITE ACRYSEAL SPRAY SEALANT Enamelite, LLC | EBD |
| Oct 24, 2008 | K082285 | EASY GLAZE Voco GmbH, DE | EBD |
| May 13, 2008 | K080549 | DURAFINISH ALL-CURE, MODEL S296 Parkell, Inc. | EBD |
| Feb 8, 2008 | K073243 | LED PRO SEAL Reliance Orthodontic Products, Inc. | EBD |
| Mar 22, 2007 | K070306 | PAINT- ON POLISH AGENT Dentsply International, Inc. | EBD |
| Dec 8, 2006 | K063228 | SURFACE COAT Kuraray America, Inc. | EBD |
| Oct 20, 2005 | K052462 | G-COAT GC America, Inc. | EBD |
| Aug 22, 2005 | K051999 | BISCOVER LED Bisco, Inc. | EBD |
| Feb 1, 2005 | K043168 | BISCOVER LV Bisco, Inc. | EBD |
| Apr 9, 2004 | K040599 | PARKELL RESIN GLAZE Parkell, Inc. | EBD |
| May 6, 2003 | K030646 | BELLEGLASS POINT 4 Kerr Dental Materials Center | EBD |
| Apr 28, 2003 | K030585 | SCULPTING RESIN Bisco, Inc. | EBD |
| Feb 19, 2003 | K030354 | BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER Bisco, Inc. | EBD |
| Feb 6, 2003 | K024046 | TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P Bisco, Inc. | EBD |
| Aug 1, 2002 | K021503 | UNINHIBITED Bisco, Inc. | EBD |
| Feb 14, 2002 | K011239 | GINDA GUARD Cosmedent, Inc. | EBD |
| Oct 12, 2001 | K013179 | LUXAGLAZE Dmg USA, Inc. | EBD |
| Aug 27, 1999 | K992067 | BELLEGLAZE Kerr Dental Materials Center | EBD |
| Feb 4, 1999 | K984037 | CORE-IDE Roydent Dental Products, Inc. | EBD |
| Mar 9, 1998 | K980298 | FLOWABLE HYBRID Cosmedent, Inc. | EBD |
| Feb 10, 1998 | K974494 | RENAMEL FLOWABLE COMPOSITE Cosmedent, Inc. | EBD |
| Jan 21, 1994 | K935689 | IONOSIT BASE LINER Foremost Dental Mfg., Co. | EBD |
| May 15, 1991 | K904135 | FOUNDATION HYBRID COMPOSITE Nulite Systems Research, AU | EBD |
| Apr 19, 1990 | K901050 | NO-STICK COMPOSITE INSTRUMENT DIP Pulpdent Corp. | EBD |
| Jul 22, 1986 | K862590 | 3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS) 3M Company | EBD |
| Jan 30, 1986 | K854957 | AUSTENAL DENTAL COMPOSITE RESIN Austenal Dental, Inc. | EBD |
| Aug 19, 1985 | K844845 | ESPE KETAC-BOND Espe GmbH (Us) | EBD |
| May 15, 1985 | K850610 | PEPSODENT DENTURE ADHESIVE CREAM Lever Brothers Company, Inc. | EBD |
| Mar 25, 1985 | K850675 | CURAY JOIN DENT DENTIN PRIMER Scientific Pharmaceuticals, Inc. | EBD |
| Mar 18, 1985 | K850641 | CAULK DYCAL LIGHT CURED Dentsply Intl. | EBD |
| Feb 8, 1985 | K850073 | J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT Johnson & Johnson Professionals, Inc. | EBD |
| May 11, 1984 | K840751 | OPAQUE COATING & SURFACE STAIN Dentsply Intl. | EBD |
| Sep 29, 1983 | K832834 | CONCISE 2 SMALL PARTICLE LIGHT CURVED 3M Company | EBD |
| Dec 28, 1982 | K823732 | CBM, CORE BUILD-UP MATERIAL Scientific Pharmaceuticals, Inc. | EBD |
| Oct 13, 1982 | K822869 | COMMAND BONDING RESIN/GLAZE/OPAQUER Sybron Corp. | EBD |
| Sep 28, 1982 | K822714 | CONCLUDE COMPOSITE LUTING CEMENT 3M Company | EBD |
| Feb 24, 1982 | K813328 | MYERSON/KENSON GP POLYMER Howmedica Corp. | EBD |
| Apr 14, 1981 | K810813 | DMG-POLISHABLE COMPOSITE Dental-Material Gesellschaft | EBD |
| Aug 10, 1979 | K791078 | ANTERIOR/POSTERIOR RESTORATIVE, BOND Scientific Pharmaceuticals, Inc. | EBD |
| Aug 10, 1979 | K791067 | SCI-PHARM PAINT-ON RESTORATIVE Scientific Pharmaceuticals, Inc. | EBD |
| Apr 10, 1979 | K790438 | COLORANT Vivadent (Usa), Inc. | EBD |
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