EBD — Coating, Filling Material, Resin Class II
FDA product code EBD covers "Coating, Filling Material, Resin", a Class II medical device regulated under 21 CFR 872.3310. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EBD
- Device Class
- Class II
- Regulation Number
- 872.3310
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254091 | yamahachi dental mfg | GLOSSY COAT (15ML) | April 6, 2026 |
| K250804 | id korea co | ID LIGHT CURE SYSTEM | June 4, 2025 |
| K240735 | bredent gmbh and co. kg | visio.lign color, visio.lign shield | December 12, 2024 |
| K223365 | belport company, inc., gingi-pak | RODIN Palette Naturalizing Kit | March 27, 2023 |
| K211854 | vita zahnfabrik gmbh h rauter and | VITA Akzent LC | November 22, 2021 |
| K162408 | dreve dentamid | Nano Varnish, Plaquit, Lightpaint on Surface | April 5, 2018 |
| K163568 | shofu dental corporation | SHOFU RESIN GLAZE | August 16, 2017 |
| K133836 | gc america | OPTIGLAZE COLOR | March 6, 2014 |
| K123761 | innovation meditech | VITA ENAMIC STAINS | March 1, 2013 |
| K093019 | enamelite | ENAMELITE ACRYSEAL SPRAY SEALANT | December 22, 2009 |
| K082285 | voco | EASY GLAZE | October 24, 2008 |
| K080549 | parkell | DURAFINISH ALL-CURE, MODEL S296 | May 13, 2008 |
| K073243 | reliance orthodontic products | LED PRO SEAL | February 8, 2008 |
| K070306 | dentsply international | PAINT- ON POLISH AGENT | March 22, 2007 |
| K063228 | kuraray america | SURFACE COAT | December 8, 2006 |
| K052462 | gc america | G-COAT | October 20, 2005 |
| K051999 | bisco | BISCOVER LED | August 22, 2005 |
| K043168 | bisco | BISCOVER LV | February 1, 2005 |
| K040599 | parkell | PARKELL RESIN GLAZE | April 9, 2004 |
| K030646 | kerr dental materials center | BELLEGLASS POINT 4 | May 6, 2003 |