Clearance Summary
Dental Handpiece received FDA 510(k) clearance under submission number K192809, 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 2020-08-25.
- Submission: K192809
- Applicant / Sponsor: Micro-Nx Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2020-08-25
Classification & Regulation
This clearance is catalogued under FDA product code EFA and 21 CFR 872.4200, within the Dental review panel as a Class I device.