Cleared Traditional

K854995 - DENCLENZ

K854995 is an FDA 510(k) clearance for DENCLENZ, manufactured by Creighton Products Corp.. The device is a Class 1 Dental device with product code EFT cleared through the Traditional 510(k) pathway after a 151-day FDA review.

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

FDA 510(k) Submission Details - K854995

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
23d slower than avg
Panel avg: 128d · This submission: 151d
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.