Clearance Summary
ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW received FDA 510(k) clearance under submission number K081393, sponsored by G & H Wire Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-08-21.
- Submission: K081393
- Applicant / Sponsor: G & H Wire Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2008-08-21
Classification & Regulation
This clearance is catalogued under FDA product code OAT and 21 CFR 872.3640, within the Dental review panel as a Class II device.