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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 K212910
Device Name Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
Applicant
Shenzhen Carejoy Technology Co., Ltd.
5 / F, Bldg. E, #10, E. Snow Science And Technology,
On Sakata St., Longgang District
Shenzhen,  CN 518129
Applicant Contact Wei Hui
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Rm. 1407, Jingting Bldg., Dongzhou Community, Guangming
St., Guangming District
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number872.4200
Classification Product Code
EFB  
Subsequent Product Code
EGS  
Date Received09/13/2021
Decision Date 11/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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