Clearance Summary
T.B.R. ZIRCONNECT received FDA 510(k) clearance under submission number K070935, sponsored by Sudimplant SA. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2007-11-09.
- Submission: K070935
- Applicant / Sponsor: Sudimplant SA
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2007-11-09
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.