Clearance Summary
HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY received FDA 510(k) clearance under submission number K875344, sponsored by Kulzer, 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 1988-03-18.
- Submission: K875344
- Applicant / Sponsor: Kulzer, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3070
- Decision date: 1988-03-18
Classification & Regulation
This clearance is catalogued under FDA product code EJJ and 21 CFR 872.3070, within the Dental review panel as a Class II device.