Clearance Summary
SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT received FDA 510(k) clearance under submission number K083876, sponsored by Cendres & Metaux SA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2010-02-26.
- Submission: K083876
- Applicant / Sponsor: Cendres & Metaux SA
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2010-02-26
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.