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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coating, Filling Material, Resin
510(k) Number K254091
Device Name GLOSSY COAT (15ML)
Applicant
YAMAHACHI DENTAL MFG., Co.
54-1 Ochigara, Nishiura-Cho
Gamagori,  JP 443-0105
Applicant Contact Toyama Masashi
Correspondent
YAMAHACHI DENTAL MFG., Co.
54-1 Ochigara, Nishiura-Cho
Gamagori,  JP 443-0105
Correspondent Contact Hirota Shuhei
Regulation Number872.3310
Classification Product Code
EBD  
Date Received12/19/2025
Decision Date 04/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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