Clearance Summary
Dental High-speed Handpiece and Accessories received FDA 510(k) clearance under submission number K173943, sponsored by Microp Technology (Taiwan), Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2018-07-24.
- Submission: K173943
- Applicant / Sponsor: Microp Technology (Taiwan), Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2018-07-24
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.