Clearance Summary
TISMESH SYSTEM received FDA 510(k) clearance under submission number K923419, sponsored by Ti-Mesh, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1993-04-08.
- Submission: K923419
- Applicant / Sponsor: Ti-Mesh, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 1993-04-08
Classification & Regulation
This clearance is catalogued under FDA product code JEY and 21 CFR 872.4760, within the Dental review panel as a Class II device.