Clearance Summary
Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece received FDA 510(k) clearance under submission number K212910, sponsored by Shenzhen Carejoy Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2022-11-17.
- Submission: K212910
- Applicant / Sponsor: Shenzhen Carejoy Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2022-11-17
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.