Clearance Summary
KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10 received FDA 510(k) clearance under submission number K112758, sponsored by Kat Implants, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-02-23.
- Submission: K112758
- Applicant / Sponsor: Kat Implants, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2012-02-23
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.