Clearance Summary
ULTRA SPHERICAL AMALGAM ALLOY received FDA 510(k) clearance under submission number K951865, sponsored by Goldsmith & Revere, 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 1995-05-25.
- Submission: K951865
- Applicant / Sponsor: Goldsmith & Revere, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3070
- Decision date: 1995-05-25
Classification & Regulation
This clearance is catalogued under FDA product code EJJ and 21 CFR 872.3070, within the Dental review panel as a Class II device.