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FDA 510(k)

GLOSSY COAT (15ML)

K-Number: K254091 · 2026-04-06

ApplicantYAMAHACHI DENTAL MFG., Co.
Decision Date2026-04-06
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GLOSSY COAT (15ML) is a medical device manufactured by YAMAHACHI DENTAL MFG., Co.. It received FDA 510(k) clearance on 2026-04-06 under approval number K254091. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOSSY COAT (15ML)?

GLOSSY COAT (15ML) is a medical device that received FDA 510(k) clearance on 2026-04-06. It is manufactured by YAMAHACHI DENTAL MFG., Co.. The 510(k) number is K254091.

When was GLOSSY COAT (15ML) approved by the FDA?

GLOSSY COAT (15ML) received FDA 510(k) clearance on 2026-04-06, under approval number K254091.

What company makes GLOSSY COAT (15ML)?

GLOSSY COAT (15ML) is manufactured by YAMAHACHI DENTAL MFG., Co..

What is the FDA product code for GLOSSY COAT (15ML)?

The FDA product code for GLOSSY COAT (15ML) is EBD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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