Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3310](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3310) → EBD — Coating, Filling Material, Resin # EBD · Coating, Filling Material, Resin _Dental · 21 CFR 872.3310 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD ## Overview - **Product Code:** EBD - **Device Name:** Coating, Filling Material, Resin - **Regulation:** [21 CFR 872.3310](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3310) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **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](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K254091.md) | GLOSSY COAT (15ML) | YAMAHACHI DENTAL MFG., Co. | Apr 6, 2026 | SESE | | [K250804](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K250804.md) | ID LIGHT CURE SYSTEM | Id Korea Co., Ltd. | Jun 4, 2025 | SESE | | [K240735](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K240735.md) | visio.lign color, visio.lign shield | Bredent GmbH & Co. KG | Dec 12, 2024 | SESE | | [K223365](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K223365.md) | RODIN Palette Naturalizing Kit | Belport Company, Inc., Gingi-Pak | Mar 27, 2023 | SESE | | [K211854](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K211854.md) | VITA Akzent LC | Vita Zahnfabrik GmbH H Rauter & CO | Nov 22, 2021 | SESE | | [K162408](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K162408.md) | Nano Varnish, Plaquit, Lightpaint on Surface | Dreve Dentamid GmbH | Apr 5, 2018 | SESE | | [K163568](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K163568.md) | SHOFU RESIN GLAZE | Shofu Dental Corporation | Aug 16, 2017 | SESE | | [K133836](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K133836.md) | OPTIGLAZE COLOR | GC America, Inc. | Mar 6, 2014 | SESE | | [K123761](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K123761.md) | VITA ENAMIC STAINS | Innovation Meditech GmbH | Mar 1, 2013 | SESE | | [K093019](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K093019.md) | ENAMELITE ACRYSEAL SPRAY SEALANT | Enamelite, LLC | Dec 22, 2009 | SESE | | [K082285](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K082285.md) | EASY GLAZE | Voco GmbH | Oct 24, 2008 | SESE | | [K080549](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K080549.md) | DURAFINISH ALL-CURE, MODEL S296 | Parkell, Inc. | May 13, 2008 | SESE | | [K073243](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K073243.md) | LED PRO SEAL | Reliance Orthodontic Products, Inc. | Feb 8, 2008 | SESE | | [K070306](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K070306.md) | PAINT- ON POLISH AGENT | Dentsply International, Inc. | Mar 22, 2007 | SESE | | [K063228](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K063228.md) | SURFACE COAT | Kuraray America, Inc. | Dec 8, 2006 | SESE | | [K052462](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K052462.md) | G-COAT | GC America, Inc. | Oct 20, 2005 | SESE | | [K051999](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K051999.md) | BISCOVER LED | Bisco, Inc. | Aug 22, 2005 | SESE | | [K043168](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K043168.md) | BISCOVER LV | Bisco, Inc. | Feb 1, 2005 | SESE | | [K040599](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K040599.md) | PARKELL RESIN GLAZE | Parkell, Inc. | Apr 9, 2004 | SESE | | [K030646](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K030646.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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