Clearance Summary
GOLD-PALLADIUM-SILVER BASED CAST/ALLOY received FDA 510(k) clearance under submission number K833736, sponsored by Jeneric Ind.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1983-12-29.
- Submission: K833736
- Applicant / Sponsor: Jeneric Ind.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1983-12-29
Classification & Regulation
This clearance is catalogued under FDA product code EIS and 21 CFR 872.4565, within the Dental review panel as a Class I device.