Clearance Summary
JET SET 4 DENTURE REPAIR RESIN received FDA 510(k) clearance under submission number K152981, sponsored by Lang Dental Manufacturing Company, 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 2016-09-02.
- Submission: K152981
- Applicant / Sponsor: Lang Dental Manufacturing Company, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 2016-09-02
Classification & Regulation
This clearance is catalogued under FDA product code EBI and 21 CFR 872.3760, within the Dental review panel as a Class II device.