Clearance Summary
Straumann TLX Implant System received FDA 510(k) clearance under submission number K200586, sponsored by Institut Straumann AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-08-20.
- Submission: K200586
- Applicant / Sponsor: Institut Straumann AG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2020-08-20
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.