GLOSSY COAT (15ML)— 510(k) K254091

Substantially Equivalent

YAMAHACHI 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.

Clearance details

Applicant: YAMAHACHI DENTAL MFG., Co.
Product code: Code EBD
Device class: Class 2
Regulation: 21 CFR 872.3310
Advisory panel: Dental
Date received: 2025-12-19
Decision date: 2026-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gamagori, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.