← Product Code [EBD](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD) · K254091

# GLOSSY COAT (15ML) (K254091)

_YAMAHACHI DENTAL MFG., Co. · EBD · Apr 6, 2026 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K254091

## Device Facts

- **Applicant:** YAMAHACHI DENTAL MFG., Co.
- **Product Code:** [EBD](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD.md)
- **Decision Date:** Apr 6, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3310
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K254091](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K254091)

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