Clearance Summary
ENDOSSOUS IMPLANTS received FDA 510(k) clearance under submission number K021322, 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 2002-07-24.
- Submission: K021322
- Applicant / Sponsor: Intra-Lock International
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2002-07-24
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.