Clearance Summary
DENDIA WERK BURS AND CUTTING DISCS received FDA 510(k) clearance under submission number K901967, 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 1990-07-13.
- Submission: K901967
- Applicant / Sponsor: Micro-Aire Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4535
- Decision date: 1990-07-13
Classification & Regulation
This clearance is catalogued under FDA product code DZP and 21 CFR 872.4535, within the Dental review panel as a Class I device.