Clearance Summary
PALCERAM 53 received FDA 510(k) clearance under submission number K001479, sponsored by Aurex SA (Pty) , 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 2000-06-21.
- Submission: K001479
- Applicant / Sponsor: Aurex SA (Pty) , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3060
- Decision date: 2000-06-21
Classification & Regulation
This clearance is catalogued under FDA product code EJT and 21 CFR 872.3060, within the Dental review panel as a Class II device.