Clearance Summary
3.75MM AND 5.0MM SPLINE TWIST IMPLANT received FDA 510(k) clearance under submission number K013494, sponsored by Sulzer Dental, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-01-18.
- Submission: K013494
- Applicant / Sponsor: Sulzer Dental, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2002-01-18
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.