Clearance Summary
TRUETECH MEDICAL, INC. DENTURE CUPS received FDA 510(k) clearance under submission number K871160, sponsored by Zenex Medical, 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 1987-06-23.
- Submission: K871160
- Applicant / Sponsor: Zenex Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3590
- Decision date: 1987-06-23
Classification & Regulation
This clearance is catalogued under FDA product code ELM and 21 CFR 872.3590, within the Dental review panel as a Class II device.