Endo Motor

Handpiece, Direct Drive, Ac-powered

Foshan CICADA Dental Instrument Co., Ltd.

The following data is part of a premarket notification filed by Foshan Cicada Dental Instrument Co., Ltd. with the FDA for Endo Motor.

Pre-market Notification Details

Device IDK192649
510k NumberK192649
Device Name:Endo Motor
ClassificationHandpiece, Direct Drive, Ac-powered
Applicant Foshan CICADA Dental Instrument Co., Ltd. B5-2F, Guangdong New Light Source Industrial Base Shihan Town, Nanhai District, Foshan,  CN
ContactJuan Liu
CorrespondentJet Li
Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou,  CN
Product CodeEKX  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-24
Decision Date2021-03-12

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