Clearance Summary
SUPREMCAST received FDA 510(k) clearance under submission number K011705, sponsored by American Dent-All, 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 2001-08-03.
- Submission: K011705
- Applicant / Sponsor: American Dent-All, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3710
- Decision date: 2001-08-03
Classification & Regulation
This clearance is catalogued under FDA product code EJH and 21 CFR 872.3710, within the Dental review panel as a Class II device.