Clearance Summary
TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM received FDA 510(k) clearance under submission number K112585, sponsored by Adin Dental Implants System, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-05-24.
- Submission: K112585
- Applicant / Sponsor: Adin Dental Implants System, Ltd.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2012-05-24
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.