Clearance Summary
STARCERAM received FDA 510(k) clearance under submission number K081263, sponsored by H.C. Starck Ceramics GmbH & Co.Kg. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-07-01.
- Submission: K081263
- Applicant / Sponsor: H.C. Starck Ceramics GmbH & Co.Kg
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2008-07-01
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.