Clearance Summary
IMPLANDRILL - THREADED DENTAL IMPLANT received FDA 510(k) clearance under submission number K913404, sponsored by Impladrill , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1993-03-31.
- Submission: K913404
- Applicant / Sponsor: Impladrill , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1993-03-31
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.