Product code EBD
- Device name
- Coating, Filling Material, Resin
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3310
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254091 | GLOSSY COAT (15ML) | YAMAHACHI DENTAL MFG., Co. | 2026-04-06 |
| K250804 | ID LIGHT CURE SYSTEM | Id Korea Co., Ltd. | 2025-06-04 |
| K240735 | visio.lign color, visio.lign shield | Bredent GmbH & Co. KG | 2024-12-12 |
| K223365 | RODIN Palette Naturalizing Kit | Belport Company, Inc., Gingi-Pak | 2023-03-27 |
| K211854 | VITA Akzent LC | Vita Zahnfabrik GmbH H Rauter & CO | 2021-11-22 |
| K162408 | Nano Varnish, Plaquit, Lightpaint on Surface | Dreve Dentamid GmbH | 2018-04-05 |
| K163568 | SHOFU RESIN GLAZE | Shofu Dental Corporation | 2017-08-16 |
| K133836 | OPTIGLAZE COLOR | GC America, Inc. | 2014-03-06 |
| K123761 | VITA ENAMIC STAINS | Innovation Meditech GmbH | 2013-03-01 |
| K093019 | ENAMELITE ACRYSEAL SPRAY SEALANT | Enamelite, LLC | 2009-12-22 |
| K082285 | EASY GLAZE | Voco GmbH | 2008-10-24 |
| K080549 | DURAFINISH ALL-CURE, MODEL S296 | Parkell, Inc. | 2008-05-13 |
| K073243 | LED PRO SEAL | Reliance Orthodontic Products, Inc. | 2008-02-08 |
| K070306 | PAINT- ON POLISH AGENT | Dentsply International, Inc. | 2007-03-22 |
| K063228 | SURFACE COAT | Kuraray America, Inc. | 2006-12-08 |
| K052462 | G-COAT | GC America, Inc. | 2005-10-20 |
| K051999 | BISCOVER LED | Bisco, Inc. | 2005-08-22 |
| K043168 | BISCOVER LV | Bisco, Inc. | 2005-02-01 |
| K040599 | PARKELL RESIN GLAZE | Parkell, Inc. | 2004-04-09 |
| K030646 | BELLEGLASS POINT 4 | Kerr Dental Materials Center | 2003-05-06 |
| K030585 | SCULPTING RESIN | Bisco, Inc. | 2003-04-28 |
| K030354 | BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER | Bisco, Inc. | 2003-02-19 |
| K024046 | TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P | Bisco, Inc. | 2003-02-06 |
| K021503 | UNINHIBITED | Bisco, Inc. | 2002-08-01 |
| K011239 | GINDA GUARD | Cosmedent, Inc. | 2002-02-14 |
| K013179 | LUXAGLAZE | Dmg USA, Inc. | 2001-10-12 |
| K992067 | BELLEGLAZE | Kerr Dental Materials Center | 1999-08-27 |
| K984037 | CORE-IDE | Roydent Dental Products, Inc. | 1999-02-04 |
| K980298 | FLOWABLE HYBRID | Cosmedent, Inc. | 1998-03-09 |
| K974494 | RENAMEL FLOWABLE COMPOSITE | Cosmedent, Inc. | 1998-02-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809896990288 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-15 |
| 08809896990295 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990516 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990509 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990493 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990486 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990479 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990462 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990455 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990448 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990431 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990424 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990417 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990400 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990387 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990271 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990264 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990257 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990240 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990233 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990226 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990219 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990202 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990196 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990189 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990172 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-14 |
| 08809896990394 | ID LIGHTCURE SYSTEM | ID KOREA CO., LTD. | 2026-05-12 |
| J001702011043800 | Ketac™ Bond | 3M Deutschland GmbH | 2016-09-24 |
| J001702011101550 | Ketac™ Bond | 3M Deutschland GmbH | 2016-09-24 |
| J001702011044060 | Ketac™ Bond | 3M Deutschland GmbH | 2016-09-24 |