Cleared Traditional

K831493 - DENTURE ADHESIVE SEALS (FDA 510(k) Clearance)

Class I Dental device.

K831493 · Johnson & Johnson Professionals, Inc. · Dental device
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Jun 1983
Decision
51d
Days
Class 1
Risk

K831493 is an FDA 510(k) clearance for the DENTURE ADHESIVE SEALS. Classified as Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-sodium (product code KOT), Class I - General Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 51 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K831493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1983
Decision Date June 30, 1983
Days to Decision 51 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 127d · This submission: 51d
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.