Clearance Summary
ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH received FDA 510(k) clearance under submission number K991822, sponsored by Dr. Ihde Dental AG Switzerland. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2001-08-15.
- Submission: K991822
- Applicant / Sponsor: Dr. Ihde Dental AG Switzerland
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2001-08-15
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.