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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 K251389
Device Name High speed air turbine handpiece
Applicant
Foshan Topmed Dental Co., Ltd.
Rm. 401, Floor 4, Block C, #7, Gui Dan Rd. Side Section
Luo Cun St., Shi Shan Nanhai District
Foshan,  CN 528226
Applicant Contact Salon Chen
Correspondent
Imd Medical & Drug Technology Service Institutions
Rm. 308, Bldg. 11
# 23 Jinqu Rd., Wanjiang District
Dongguan,  CN 523932
Correspondent Contact Salon Chen
Regulation Number872.4200
Classification Product Code
EFB  
Date Received05/05/2025
Decision Date 01/12/2026
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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