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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,Avenue Nanhai
Foshan,  CN 528226
Applicant Contact Zheng Yongjian
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North 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
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