Clearance Summary
BEGO Semados® RS/RSX Implant System received FDA 510(k) clearance under submission number K201700, 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 2021-01-13.
- Submission: K201700
- 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: 2021-01-13
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.