Clearance Summary
SMARTBURS received FDA 510(k) clearance under submission number K080687, sponsored by S.S. White Burs, 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 2008-06-20.
- Submission: K080687
- Applicant / Sponsor: S.S. White Burs, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3240
- Decision date: 2008-06-20
Classification & Regulation
This clearance is catalogued under FDA product code EJL and 21 CFR 872.3240, within the Dental review panel as a Class I device.