FDA Product Code
FDA Product Code EBD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3310
510(k) Clearances — 52 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254091 | GLOSSY COAT (15ML) | YAMAHACHI DENTAL MFG., Co. | 2026-04-06 | Traditional | PDF ↗ |
| K250804 | ID LIGHT CURE SYSTEM | Id Korea Co., Ltd. | 2025-06-04 | Traditional | PDF ↗ |
| K240735 | visio.lign color, visio.lign shield | Bredent GmbH & Co. KG | 2024-12-12 | Traditional | PDF ↗ |
| K223365 | RODIN Palette Naturalizing Kit | Belport Company, Inc., Gingi-Pak | 2023-03-27 | Traditional | PDF ↗ |
| K211854 | VITA Akzent LC | Vita Zahnfabrik GmbH H Rauter & CO | 2021-11-22 | Traditional | PDF ↗ |
| K162408 | Nano Varnish, Plaquit, Lightpaint on Surface | Dreve Dentamid GmbH | 2018-04-05 | Traditional | PDF ↗ |
| K163568 | SHOFU RESIN GLAZE | Shofu Dental Corporation | 2017-08-16 | Traditional | PDF ↗ |
| K133836 | OPTIGLAZE COLOR | GC America, Inc. | 2014-03-06 | Traditional | PDF ↗ |
| K123761 | VITA ENAMIC STAINS | Innovation Meditech GmbH | 2013-03-01 | Traditional | PDF ↗ |
| K093019 | ENAMELITE ACRYSEAL SPRAY SEALANT | Enamelite, LLC | 2009-12-22 | Traditional | PDF ↗ |
| K082285 | EASY GLAZE | Voco GmbH | 2008-10-24 | Traditional | PDF ↗ |
| K080549 | DURAFINISH ALL-CURE, MODEL S296 | Parkell, Inc. | 2008-05-13 | Traditional | PDF ↗ |
| K073243 | LED PRO SEAL | Reliance Orthodontic Products, Inc. | 2008-02-08 | Traditional | PDF ↗ |
| K070306 | PAINT- ON POLISH AGENT | Dentsply International, Inc. | 2007-03-22 | Traditional | PDF ↗ |
| K063228 | SURFACE COAT | Kuraray America, Inc. | 2006-12-08 | Traditional | PDF ↗ |
| K052462 | G-COAT | GC America, Inc. | 2005-10-20 | Traditional | PDF ↗ |
| K051999 | BISCOVER LED | Bisco, Inc. | 2005-08-22 | Traditional | PDF ↗ |
| K043168 | BISCOVER LV | Bisco, Inc. | 2005-02-01 | Traditional | PDF ↗ |
| K040599 | PARKELL RESIN GLAZE | Parkell, Inc. | 2004-04-09 | Traditional | PDF ↗ |
| K030646 | BELLEGLASS POINT 4 | Kerr Dental Materials Center | 2003-05-06 | Traditional | PDF ↗ |
| K030585 | SCULPTING RESIN | Bisco, Inc. | 2003-04-28 | Traditional | PDF ↗ |
| K030354 | BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER | Bisco, Inc. | 2003-02-19 | Special | PDF ↗ |
| K024046 | TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P | Bisco, Inc. | 2003-02-06 | Traditional | PDF ↗ |
| K021503 | UNINHIBITED | Bisco, Inc. | 2002-08-01 | Traditional | PDF ↗ |
| K011239 | GINDA GUARD | Cosmedent, Inc. | 2002-02-14 | Traditional | PDF ↗ |
| K013179 | LUXAGLAZE | Dmg USA, Inc. | 2001-10-12 | Traditional | PDF ↗ |
| K992067 | BELLEGLAZE | Kerr Dental Materials Center | 1999-08-27 | Traditional | PDF ↗ |
| K984037 | CORE-IDE | Roydent Dental Products, Inc. | 1999-02-04 | Traditional | PDF ↗ |
| K980298 | FLOWABLE HYBRID | Cosmedent, Inc. | 1998-03-09 | Traditional | PDF ↗ |
| K974494 | RENAMEL FLOWABLE COMPOSITE | Cosmedent, Inc. | 1998-02-10 | Traditional | PDF ↗ |
| K935689 | IONOSIT BASE LINER | Foremost Dental Mfg., Co. | 1994-01-21 | Traditional | PDF ↗ |
| K904135 | FOUNDATION HYBRID COMPOSITE | Nulite Systems Research | 1991-05-15 | Traditional | PDF ↗ |
| K901050 | NO-STICK COMPOSITE INSTRUMENT DIP | Pulpdent Corp. | 1990-04-19 | Traditional | PDF ↗ |
| K862590 | 3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS) | 3M Company | 1986-07-22 | Traditional | PDF ↗ |
| K854957 | AUSTENAL DENTAL COMPOSITE RESIN | Austenal Dental, Inc. | 1986-01-30 | Traditional | PDF ↗ |
| K844845 | ESPE KETAC-BOND | Espe GmbH (Us) | 1985-08-19 | Traditional | PDF ↗ |
| K850610 | PEPSODENT DENTURE ADHESIVE CREAM | Lever Brothers Company, Inc. | 1985-05-15 | Traditional | PDF ↗ |
| K850675 | CURAY JOIN DENT DENTIN PRIMER | Scientific Pharmaceuticals, Inc. | 1985-03-25 | Traditional | PDF ↗ |
| K850641 | CAULK DYCAL LIGHT CURED | Dentsply Intl. | 1985-03-18 | Traditional | PDF ↗ |
| K850073 | J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT | Johnson & Johnson Professionals, Inc. | 1985-02-08 | Traditional | PDF ↗ |
| K840751 | OPAQUE COATING & SURFACE STAIN | Dentsply Intl. | 1984-05-11 | Traditional | PDF ↗ |
| K832834 | CONCISE 2 SMALL PARTICLE LIGHT CURVED | 3M Company | 1983-09-29 | Traditional | PDF ↗ |
| K823732 | CBM, CORE BUILD-UP MATERIAL | Scientific Pharmaceuticals, Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K822869 | COMMAND BONDING RESIN/GLAZE/OPAQUER | Sybron Corp. | 1982-10-13 | Traditional | PDF ↗ |
| K822714 | CONCLUDE COMPOSITE LUTING CEMENT | 3M Company | 1982-09-28 | Traditional | PDF ↗ |
| K813328 | MYERSON/KENSON GP POLYMER | Howmedica Corp. | 1982-02-24 | Traditional | PDF ↗ |
| K810813 | DMG-POLISHABLE COMPOSITE | Dental-Material Gesellschaft | 1981-04-14 | Traditional | PDF ↗ |
| K791078 | ANTERIOR/POSTERIOR RESTORATIVE, BOND | Scientific Pharmaceuticals, Inc. | 1979-08-10 | Traditional | PDF ↗ |
| K791067 | SCI-PHARM PAINT-ON RESTORATIVE | Scientific Pharmaceuticals, Inc. | 1979-08-10 | Traditional | PDF ↗ |
| K790438 | COLORANT | Vivadent (Usa), Inc. | 1979-04-10 | Traditional | PDF ↗ |
| K781345 | ULTRAFILL- ULTRABOUND | Demetron Research Corp. | 1978-08-31 | Traditional | PDF ↗ |
| K760419 | ADHESION PROMOTOR | Lee Pharmaceuticals | 1976-08-23 | Traditional | PDF ↗ |
Product code EBD · Class II · Dental. Data: openFDA.