Clearance Summary
U FIT DENTAL IMPLANT SYSTEM received FDA 510(k) clearance under submission number K132956, sponsored by T Strong, 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 2014-06-05.
- Submission: K132956
- Applicant / Sponsor: T Strong, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2014-06-05
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.