Glossy Coat (15ml)
510(k) K254091
Glossy Coat (15ml) is a Class II device made by Yamahachi Dental Mfg., Co., cleared under FDA 510(k) K254091 on 6 Apr 2026, 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 | NumberK254091 | Date6 Apr 2026 | StatusActive |
Official records
- FDA 510(k) database K254091
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBD
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3310
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K254091
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| GLOSSY COAT 15ML | 15ML | D080XXGCO15MLXXXXX0 | — | On the market |
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