Clearance Summary
Noris Medical MBI-2mm Dental Implant System received FDA 510(k) clearance under submission number K162308, sponsored by Noris Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2017-03-17.
- Submission: K162308
- Applicant / Sponsor: Noris Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2017-03-17
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.