Cleared Traditional

DENTCLEAN CONCENTRATED DENTURE CLEANSER (K890043) - FDA 510(k) Clearance

Class I Dental device.

K890043 · K-P Co. · Dental device
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Jun 1989
Decision
153d
Days
Class 1
Risk

K890043 is an FDA 510(k) clearance for the DENTCLEAN CONCENTRATED DENTURE CLEANSER. Classified as Cleanser, Denture, Over The Counter (product code EFT), Class I - General Controls.

Submitted by K-P Co. (Cincinnati, US). The FDA issued a Cleared decision on June 7, 1989 after a review of 153 days - an extended review cycle.

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 K-P Co. devices

Submission Details

510(k) Number K890043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1989
Decision Date June 07, 1989
Days to Decision 153 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 127d · This submission: 153d
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.