Bright Bond Universal
510(k) K200153
Bright Bond Universal is a Class II device made by GENOSS CO., Ltd., cleared under FDA 510(k) K200153 on 28 Oct 2020, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200153 | Date28 Oct 2020 | StatusActive |
Official records
- FDA 510(k) database K200153
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KLE
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3200
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code KLE (Agent, Tooth Bonding, Resin).
- ADPER PROMPT by 3M Espe AG Dental Products
- PERMAQUICK SE BONDING SYSTEM by ULTRADENT PRODUCTS, INC.
- AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE by AMERICAN DENTAL PRODUCTS INC
- DIAETCH Refill Package Type A A2001-3202 by DiaDent Group International
- PERTAC BOND by Espe GmbH (Us)
- MODIFICATION TO CLEARFIL LINER BOND 2V by Kuraray Medical, Inc.
- XR PRIMER by Kerr Corporation (Danbury)
- Futurabond U 1578 by VOCO GmbH
- iBond Universal & iBond Ceramic Primer by Heraeus Kulzer, LLC (Mitsui Chemicals Group)
- ONE COAT 7 UNIVERSAL 60019540 by Coltène/Whaledent AG