Clearance Summary
COMPLETE DENTURE REPAIR KIT received FDA 510(k) clearance under submission number K850927, sponsored by Tooth Aid Lab, 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 1985-07-02.
- Submission: K850927
- Applicant / Sponsor: Tooth Aid Lab, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3570
- Decision date: 1985-07-02
Classification & Regulation
This clearance is catalogued under FDA product code EBO and 21 CFR 872.3570, within the Dental review panel as a Class II device.