E-connect S Endo Motor With Built-in Apex Locator

Handpiece, Direct Drive, Ac-powered

Changzhou Sifary Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Changzhou Sifary Medical Technology Co., Ltd. with the FDA for E-connect S Endo Motor With Built-in Apex Locator.

Pre-market Notification Details

Device IDK201993
510k NumberK201993
Device Name:E-connect S Endo Motor With Built-in Apex Locator
ClassificationHandpiece, Direct Drive, Ac-powered
Applicant Changzhou Sifary Medical Technology Co., Ltd. No. 99, Qingyang Road, Xuejia County, Xinbei District Changzhou City,  CN 213000
ContactAmanda Zhu
CorrespondentKevin Wang
Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue. Nanshan District Shenzhen,,  CN 518067
Product CodeEKX  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-17
Decision Date2021-01-29

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