Clearance Summary
UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT received FDA 510(k) clearance under submission number K080162, sponsored by Mis Implants Technologies , 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 2008-04-22.
- Submission: K080162
- Applicant / Sponsor: Mis Implants Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2008-04-22
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.