GLOSSY COAT (15ML)
Device Facts
| Record ID | K254091 |
|---|---|
| Device Name | GLOSSY COAT (15ML) |
| Applicant | YAMAHACHI DENTAL MFG., Co. |
| Product Code | EBD · Dental |
| Decision Date | Apr 6, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3310 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.
