The following data is part of a premarket notification filed by Foshan Cicada Dental Instrument Co., Ltd. with the FDA for Endo Motor.
| Device ID | K192649 |
| 510k Number | K192649 |
| Device Name: | Endo Motor |
| Classification | Handpiece, 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 |
| Contact | Juan Liu |
| Correspondent | Jet Li Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-24 |
| Decision Date | 2021-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974456210259 | K192649 | 000 |