Clearance Summary
Universal CMF System received FDA 510(k) clearance under submission number K221855, sponsored by Stryker Leibinger 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 2022-11-09.
- Submission: K221855
- Applicant / Sponsor: Stryker Leibinger GmbH & Co KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2022-11-09
Classification & Regulation
This clearance is catalogued under FDA product code JEY and 21 CFR 872.4760, within the Dental review panel as a Class II device.