Cleared Traditional

K942203 - OTC DENTURE CLEANSER

K942203 is an FDA 510(k) clearance for OTC DENTURE CLEANSER, manufactured by Combe, Inc.. The device is a Class 1 Dental device with product code EFT cleared through the Traditional 510(k) pathway after a 97-day FDA review.

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

FDA 510(k) Submission Details - K942203

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.

EFT Device Classification - Class 1, General Controls

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.

Regulatory Peers - EFT Cleanser, Denture, Over The Counter

Devices cleared under the same product code (EFT) and FDA review panel - the closest regulatory comparables to K942203.
CLEANSE.FRESHEN.GO
K080631 · Oral Health Technologies, LLC · May 2008
MEDICAL INTERPOROUS
K051342 · Bonyf AG · Jun 2006
TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND
K000996 · Dentsply Intl. · Jun 2000
DENTURE PRODUCT X
K914257 · Essential Dental Systems, Inc. · Jan 1993
ARGILITE 4 GOLD ALLOY FOR PORCELAIN
K903686 · Argen Precious Metals, Inc. · Aug 1990