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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K262144
Device Name DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece
Applicant
SETAGAYA SEIKI Co., Ltd.
5-4862-11 Hachimanpara
Yonezawa-City,  JP 992-1128
Applicant Contact Shigehiro Sasaki
Correspondent
Ken Block Consulting, LLC
3400 N Central Expy., Suite 100-265
Richardson,  TX  75080
Correspondent Contact Akiko Dohi
Regulation Number872.4200
Classification Product Code
EFB  
Subsequent Product Code
EGS  
Date Received06/25/2026
Decision Date 09/23/2026
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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