Clearance Summary
MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL received FDA 510(k) clearance under submission number K850597, sponsored by Micro-Aire Surgical Instruments, 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 1985-03-25.
- Submission: K850597
- Applicant / Sponsor: Micro-Aire Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1985-03-25
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.