Clearance Summary
BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit received FDA 510(k) clearance under submission number K201412, sponsored by Bego Implant Systems GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2021-02-18.
- Submission: K201412
- Applicant / Sponsor: Bego Implant Systems GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2021-02-18
Classification & Regulation
This clearance is catalogued under FDA product code KCT and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.