The following data is part of a premarket notification filed by Foshan Cicada Dental Instrument Co, Ltd. with the FDA for Dental Electric Motor.
| Device ID | K202075 |
| 510k Number | K202075 |
| Device Name: | Dental Electric Motor |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | Foshan CICADA Dental Instrument Co, Ltd. B5-2F, Guangdong New Light Source Industrial Base, Nanhai District Foshan, CN 528226 |
| Contact | Juan Liu |
| Correspondent | Jet Li Guangzhou KEDA Biological Technology Co., Ltd 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN 510010 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-27 |
| Decision Date | 2022-03-11 |