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 ID | K201993 |
| 510k Number | K201993 |
| 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 |
| Contact | Amanda Zhu |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue. Nanshan District Shenzhen,, CN 518067 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-17 |
| Decision Date | 2021-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810092938637 | K201993 | 000 |
| 06972597780648 | K201993 | 000 |