Clearance Summary
DMi Dental Implant System received FDA 510(k) clearance under submission number K160060, sponsored by Dmi Innovative Medical Technology , 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 2016-10-03.
- Submission: K160060
- Applicant / Sponsor: Dmi Innovative Medical Technology , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2016-10-03
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.