Clearance Summary
Dental Handpiece, Model CA160, CA160L, and CA500L received FDA 510(k) clearance under submission number K220577, sponsored by Micro-Nx 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 2022-07-29.
- Submission: K220577
- Applicant / Sponsor: Micro-Nx Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2022-07-29
Classification & Regulation
This clearance is catalogued under FDA product code EGS and 21 CFR 872.4200, within the Dental review panel as a Class I device.