EBD — Coating, Filling Material, Resin Class II
FDA Device Classification
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 |
| 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 |
| K030585 | bisco | SCULPTING RESIN | April 28, 2003 |