Clearance Summary
CARIESCAN PRO received FDA 510(k) clearance under submission number K090598, sponsored by Cariescan , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-12-15.
- Submission: K090598
- Applicant / Sponsor: Cariescan , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1745
- Decision date: 2009-12-15
Classification & Regulation
This clearance is catalogued under FDA product code NBL and 21 CFR 872.1745, within the Dental review panel as a Class II device.