Clearance Summary
SPARTAN -ALLOY FOR PORCELAIN FUSED TO METAL received FDA 510(k) clearance under submission number K850699, sponsored by Williams Gold Refining Co., 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 1985-03-18.
- Submission: K850699
- Applicant / Sponsor: Williams Gold Refining Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3060
- Decision date: 1985-03-18
Classification & Regulation
This clearance is catalogued under FDA product code EJS and 21 CFR 872.3060, within the Dental review panel as a Class II device.