Clearance Summary
IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT received FDA 510(k) clearance under submission number K113279, sponsored by Kettenbach GmbH & Co. KG. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2011-11-14.
- Submission: K113279
- Applicant / Sponsor: Kettenbach GmbH & Co. KG
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 2011-11-14
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.