Clearance Summary
ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM received FDA 510(k) clearance under submission number K063770, sponsored by Alpha-Bio Tec , 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 2007-03-26.
- Submission: K063770
- Applicant / Sponsor: Alpha-Bio Tec , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2007-03-26
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.