MPI DENTURE ADHESIVE FILM SEALS— 510(k) K941365

Substantially Equivalent

Medical Polymers, Inc.

FDA 510(k) clearance K941365 for MPI DENTURE ADHESIVE FILM SEALS, Substantially Equivalent on 1994-04-22. Applicant: Medical Polymers, Inc..

Clearance details

Applicant: Medical Polymers, Inc.
Product code: Code KOT
Advisory panel: Dental
Date received: 1994-03-21
Decision date: 1994-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KOT

product code KOT

Death: 5
Injury: 309
Total: 314

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.