Clearance Summary
SCREW, BONE, MAXILLOFACIAL received FDA 510(k) clearance under submission number K911165, sponsored by Tekno-Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-08-20.
- Submission: K911165
- Applicant / Sponsor: Tekno-Medical
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4880
- Decision date: 1991-08-20
Classification & Regulation
This clearance is catalogued under FDA product code DZL and 21 CFR 872.4880, within the Dental review panel as a Class II device.