Clearance Summary
CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX received FDA 510(k) clearance under submission number K000981, sponsored by C-Mix. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-06-13.
- Submission: K000981
- Applicant / Sponsor: C-Mix
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3710
- Decision date: 2000-06-13
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.