Clearance Summary
DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS received FDA 510(k) clearance under submission number K940908, sponsored by Dunhall Pharmaceuticals, 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 1994-08-29.
- Submission: K940908
- Applicant / Sponsor: Dunhall Pharmaceuticals, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4535
- Decision date: 1994-08-29
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.