Cleared Traditional

DENCLENZ (K854995) - FDA 510(k) Clearance

Class I Dental device.

K854995 · Creighton Products Corp. · Dental device
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May 1986
Decision
151d
Days
Class 1
Risk

K854995 is an FDA 510(k) clearance for the DENCLENZ. Classified as Cleanser, Denture, Over The Counter (product code EFT), Class I - General Controls.

Submitted by Creighton Products Corp. (New York, US). The FDA issued a Cleared decision on May 12, 1986 after a review of 151 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 Creighton Products Corp. devices

Submission Details

510(k) Number K854995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1985
Decision Date May 12, 1986
Days to Decision 151 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 127d · This submission: 151d
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.