Clearance Summary
BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM received FDA 510(k) clearance under submission number K121131, sponsored by Straumann USA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-06-06.
- Submission: K121131
- Applicant / Sponsor: Straumann USA
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2012-06-06
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.