Clearance Summary
MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS received FDA 510(k) clearance under submission number K080598, 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 2008-05-21.
- Submission: K080598
- Applicant / Sponsor: Intra-Lock International
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2008-05-21
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.