Clearance Summary
3M UNITEK LAVA CHAIRSIDE ORAL SCANNER received FDA 510(k) clearance under submission number K081961, sponsored by Brontes Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-09-05.
- Submission: K081961
- Applicant / Sponsor: Brontes Technologies
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3661
- Decision date: 2008-09-05
Classification & Regulation
This clearance is catalogued under FDA product code NOF and 21 CFR 872.3661, within the Dental review panel as a Class II device.