Clearance Summary
GDC 1453 CASTING ALLOY received FDA 510(k) clearance under submission number K854285, sponsored by Deringer-Ney, 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 1985-12-27.
- Submission: K854285
- Applicant / Sponsor: Deringer-Ney, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3710
- Decision date: 1985-12-27
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.