Clearance Summary
PRO-TORQ received FDA 510(k) clearance under submission number K000120, sponsored by Micro Motors, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-02-03.
- Submission: K000120
- Applicant / Sponsor: Micro Motors, Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2000-02-03
Classification & Regulation
This clearance is catalogued under FDA product code EBW and 21 CFR 872.4200, within the Dental review panel as a Class I device.