Clearance Summary
TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION received FDA 510(k) clearance under submission number K002152, sponsored by KLS-Martin L.P.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-10-10.
- Submission: K002152
- Applicant / Sponsor: KLS-Martin L.P.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2000-10-10
Classification & Regulation
This clearance is catalogued under FDA product code MQN and 21 CFR 872.4760, within the Dental review panel as a Class II device.