Clearance Summary
SPIRAL LOCK DENTAL IMPLANT SYSTEM received FDA 510(k) clearance under submission number K926100, sponsored by Robert A James. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-05-23.
- Submission: K926100
- Applicant / Sponsor: Robert A James
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1994-05-23
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.