510(k) K992067
- Device
- BELLEGLAZE
- Applicant
- KERR DENTAL MATERIALS CENTER
- 510(k) number
- K992067
- Product code
- EBD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-08-27
- Date received
- 1999-06-18
- Regulation
- 872.3310
- Classification name
- Coating, Filling Material, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- COLLEEN BOSWELL
- Address
- 1717 W. Collins Ave. Orange CA US 92867 92867
FDA Registration Numbers#
- 3002789526
- 1000625496
- 3002807050
- 1410097
- 3014270094
- 3008912871
- 3006942327
- 9612352
- 2916735
- 1215305
- 3009496224
- 9611385
- 1420052
- 9612300
- 8010908
- 1000118628
- 2424472
- 1420089
- 1000303432
- 2022039
- 3038718579
- 3039359767
- 9610902
- 2411797
- 2086043
- 2241860
- 3004146043
- 3014579161
- 8044164
- 2018957
- 3002808149
- 1721647
- 3004966444
- 3006694515
- 3012187973
- 2515379
- 3020841418
- 1450653
- 3012421607
- 3035693034
- 3005665377
- 1000486347
- 9613953
Source Documents#
Other 510(k) Records For Product Code EBD #
| 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 |
Legacy Summary#
summary
FDA Review#
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