Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece

Handpiece, Air-powered, Dental

Shenzhen Carejoy Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Carejoy Technology Co., Ltd. with the FDA for Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece.

Pre-market Notification Details

Device IDK212910
510k NumberK212910
Device Name:Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
ClassificationHandpiece, Air-powered, Dental
Applicant Shenzhen Carejoy Technology Co., Ltd. 5 / F, Building E, No.10, East Snow Science And Technology, On Sakata Street, Longgang District Shenzhen,  CN 518129
ContactWei Hui
CorrespondentReanny Wang
Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen,  CN 518000
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-13
Decision Date2022-11-17

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