Clearance Summary
HELIOFORM GOLD-BASED ALLOY received FDA 510(k) clearance under submission number K990670, sponsored by C. Hafner GmbH & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1999-04-02.
- Submission: K990670
- Applicant / Sponsor: C. Hafner GmbH & Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3060
- Decision date: 1999-04-02
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.