Clearance Summary
STAR ALLOYS, LITE ALLOYS AND BRITE ALLOYS received FDA 510(k) clearance under submission number K882532, sponsored by Five Stars Alloys , 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 1988-10-19.
- Submission: K882532
- Applicant / Sponsor: Five Stars Alloys , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3060
- Decision date: 1988-10-19
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.