Cleared Traditional

MPI DENTURE ADHESIVE FILM SEALS (K941365) - FDA 510(k) Clearance

Class I Dental device.

K941365 · Medical Polymers, Inc. · Dental device
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Apr 1994
Decision
32d
Days
Class 1
Risk

K941365 is an FDA 510(k) clearance for the MPI DENTURE ADHESIVE FILM SEALS. Classified as Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-sodium (product code KOT), Class I - General Controls.

Submitted by Medical Polymers, Inc. (Austin, US). The FDA issued a Cleared decision on April 22, 1994 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3490 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Polymers, Inc. devices

Submission Details

510(k) Number K941365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1994
Decision Date April 22, 1994
Days to Decision 32 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 127d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOT Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-sodium
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3490
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.