Clearance Summary
BEGO SEMADOS S-LINE received FDA 510(k) clearance under submission number K090716, sponsored by Bego Implant Systems 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 2009-10-06.
- Submission: K090716
- Applicant / Sponsor: Bego Implant Systems GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2009-10-06
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.