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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 K220179
Device Name High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors
Applicant
Foshan Coxo Medical Instrument Co., Ltd.
Bldg. 4,District A Guangdong New Light Source Industrial
Base,South Of Luocun,Ave. Nanhai
Foshan,  CN 528226
Applicant Contact Zheng Yongjian
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui
#5, Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number872.4200
Classification Product Code
EFB  
Subsequent Product Code
EGS  
Date Received01/21/2022
Decision Date 09/22/2023
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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