The following data is part of a premarket notification filed by Shenzhen Carejoy Technology Co., Ltd. with the FDA for Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece.
| Device ID | K212910 |
| 510k Number | K212910 |
| Device Name: | Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | Shenzhen Carejoy Technology Co., Ltd. 5 / F, Building E, No.10, East Snow Science And Technology, On Sakata Street, Longgang District Shenzhen, CN 518129 |
| Contact | Wei Hui |
| Correspondent | Reanny Wang Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen, CN 518000 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-13 |
| Decision Date | 2022-11-17 |