Clearance Summary
ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY received FDA 510(k) clearance under submission number K002808, sponsored by Nordiska Dental AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-10-31.
- Submission: K002808
- Applicant / Sponsor: Nordiska Dental AB
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3070
- Decision date: 2000-10-31
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.