Clearance Summary
TRANSITIONAL IMPLANTS received FDA 510(k) clearance under submission number K021915, 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 2002-12-19.
- Submission: K021915
- Applicant / Sponsor: Intra-Lock International
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2002-12-19
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.