Clearance Summary
High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors received FDA 510(k) clearance under submission number K220179, sponsored by Foshan Coxo Medical Instrument 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 2023-09-22.
- Submission: K220179
- Applicant / Sponsor: Foshan Coxo Medical Instrument Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2023-09-22
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.