Cleared Traditional

DUO TWO LAYER DENTURE CLEANSER (K791064) - FDA 510(k) Clearance

Class I Dental device.

K791064 · Block Drug Company, Inc. · Dental device
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Oct 1979
Decision
120d
Days
Class 1
Risk

K791064 is an FDA 510(k) clearance for the DUO TWO LAYER DENTURE CLEANSER. Classified as Cleanser, Denture, Over The Counter (product code EFT), Class I - General Controls.

Submitted by Block Drug Company, Inc. (Walker, US). The FDA issued a Cleared decision on October 9, 1979 after a review of 120 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 Block Drug Company, Inc. devices

Submission Details

510(k) Number K791064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1979
Decision Date October 09, 1979
Days to Decision 120 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 127d · This submission: 120d
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.