Clearance Summary
IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM received FDA 510(k) clearance under submission number K921854, sponsored by Impla-Med. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1992-10-27.
- Submission: K921854
- Applicant / Sponsor: Impla-Med
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1992-10-27
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.