Clearance Summary
IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT received FDA 510(k) clearance under submission number K092867, sponsored by Kettenbach 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 2009-10-01.
- Submission: K092867
- Applicant / Sponsor: Kettenbach GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 2009-10-01
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.