Cleared Traditional

OTC DENTURE CLEANSER (K942203) - FDA 510(k) Clearance

Class I Dental device.

K942203 · Combe, Inc. · Dental device
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Aug 1994
Decision
97d
Days
Class 1
Risk

K942203 is an FDA 510(k) clearance for the OTC DENTURE CLEANSER. Classified as Cleanser, Denture, Over The Counter (product code EFT), Class I - General Controls.

Submitted by Combe, Inc. (White Plains, US). The FDA issued a Cleared decision on August 10, 1994 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3520 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Combe, Inc. devices

Submission Details

510(k) Number K942203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1994
Decision Date August 10, 1994
Days to Decision 97 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
30d faster than avg
Panel avg: 127d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFT Cleanser, Denture, Over The Counter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3520
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.