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.
|Device Name:||E-connect S Endo Motor With Built-in Apex Locator|
|Classification||Handpiece, Direct Drive, Ac-powered|
|Applicant||Changzhou Sifary Medical Technology Co., Ltd. No. 99, Qingyang Road, Xuejia County, Xinbei District Changzhou City, CN 213000|
Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue. Nanshan District Shenzhen,, CN 518067
|CFR Regulation Number||872.4200 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|