Clearance Summary
MPI DENTURE ADHESIVE FILM SEALS received FDA 510(k) clearance under submission number K941365, sponsored by Medical Polymers, 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 1994-04-22.
- Submission: K941365
- Applicant / Sponsor: Medical Polymers, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3490
- Decision date: 1994-04-22
Classification & Regulation
This clearance is catalogued under FDA product code KOT and 21 CFR 872.3490, within the Dental review panel as a Class I device.