EBD · Coating, Filling Material, Resin
Dental · 21 CFR 872.3310 · Class 2
Overview
| Product Code | EBD |
|---|---|
| Device Name | Coating, Filling Material, Resin |
| Regulation | 21 CFR 872.3310 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 52)
Showing 20 most recent of 52 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254091 | GLOSSY COAT (15ML) | YAMAHACHI DENTAL MFG., Co. | Apr 6, 2026 | SESE |
| K250804 | ID LIGHT CURE SYSTEM | Id Korea Co., Ltd. | Jun 4, 2025 | SESE |
| K240735 | visio.lign color, visio.lign shield | Bredent GmbH & Co. KG | Dec 12, 2024 | SESE |
| K223365 | RODIN Palette Naturalizing Kit | Belport Company, Inc., Gingi-Pak | Mar 27, 2023 | SESE |
| K211854 | VITA Akzent LC | Vita Zahnfabrik GmbH H Rauter & CO | Nov 22, 2021 | SESE |
| K162408 | Nano Varnish, Plaquit, Lightpaint on Surface | Dreve Dentamid GmbH | Apr 5, 2018 | SESE |
| K163568 | SHOFU RESIN GLAZE | Shofu Dental Corporation | Aug 16, 2017 | SESE |
| K133836 | OPTIGLAZE COLOR | GC America, Inc. | Mar 6, 2014 | SESE |
| K123761 | VITA ENAMIC STAINS | Innovation Meditech GmbH | Mar 1, 2013 | SESE |
| K093019 | ENAMELITE ACRYSEAL SPRAY SEALANT | Enamelite, LLC | Dec 22, 2009 | SESE |
| K082285 | EASY GLAZE | Voco GmbH | Oct 24, 2008 | SESE |
| K080549 | DURAFINISH ALL-CURE, MODEL S296 | Parkell, Inc. | May 13, 2008 | SESE |
| K073243 | LED PRO SEAL | Reliance Orthodontic Products, Inc. | Feb 8, 2008 | SESE |
| K070306 | PAINT- ON POLISH AGENT | Dentsply International, Inc. | Mar 22, 2007 | SESE |
| K063228 | SURFACE COAT | Kuraray America, Inc. | Dec 8, 2006 | SESE |
| K052462 | G-COAT | GC America, Inc. | Oct 20, 2005 | SESE |
| K051999 | BISCOVER LED | Bisco, Inc. | Aug 22, 2005 | SESE |
| K043168 | BISCOVER LV | Bisco, Inc. | Feb 1, 2005 | SESE |
| K040599 | PARKELL RESIN GLAZE | Parkell, Inc. | Apr 9, 2004 | SESE |
| K030646 | BELLEGLASS POINT 4 | Kerr Dental Materials Center | May 6, 2003 | SESE |
Top Applicants
- Bisco, Inc. — 6 clearances
- Scientific Pharmaceuticals, Inc. — 4 clearances
- Cosmedent, Inc. — 3 clearances
- 3M Company — 3 clearances
- Parkell, Inc. — 2 clearances
