Clearance Summary
MICRO-AIRE HIGH SPEED DRILL (2910-000) received FDA 510(k) clearance under submission number K894606, 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 1989-10-13.
- Submission: K894606
- 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: 1989-10-13
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.