Clearance Summary
INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS received FDA 510(k) clearance under submission number K031322, sponsored by Intra-Lock International. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2003-12-23.
- Submission: K031322
- Applicant / Sponsor: Intra-Lock International
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2003-12-23
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.