GLOSSY COAT (15ML)— 510(k) K254091
Substantially EquivalentYAMAHACHI DENTAL MFG., Co.
FDA 510(k) clearance K254091 for GLOSSY COAT (15ML), Substantially Equivalent on 2026-04-06. Applicant: YAMAHACHI DENTAL MFG., Co.. Device class: 2.
Summary
YAMAHACHI DENTAL MFG.'s GLOSSY COAT (15ML) is filed under product code EBD (Coating, Filling Material, Resin).
Class II, 21 CFR 872.3310. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Yamahachi Dental filed from Gamagori, Japan. The decision came 108 calendar days after FDA received it (December 19, 2025 to April 6, 2026).
Clearance details
- Applicant
- YAMAHACHI DENTAL MFG., Co.
- Product code
- Product code EBD
- Device class
- Class 2
- Regulation
- 21 CFR 872.3310
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gamagori, JP
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