Clearance Summary
DCCERAM SYSTEM received FDA 510(k) clearance under submission number K141400, sponsored by Ceramay GmbH & Co.Kg. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-01-28.
- Submission: K141400
- Applicant / Sponsor: Ceramay GmbH & Co.Kg
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2015-01-28
Classification & Regulation
This clearance is catalogued under FDA product code EIH and 21 CFR 872.6660, within the Dental review panel as a Class II device.