Clearance Summary
TOUAREG CloseFit UNP 2.75mmD received FDA 510(k) clearance under submission number K153111, sponsored by Adin Dental Implants Systems , 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 2016-05-06.
- Submission: K153111
- Applicant / Sponsor: Adin Dental Implants Systems , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2016-05-06
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.