Clearance Summary
A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY) received FDA 510(k) clearance under submission number K864826, sponsored by Austenal Dental, 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 1987-02-10.
- Submission: K864826
- Applicant / Sponsor: Austenal Dental, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3710
- Decision date: 1987-02-10
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.