Cleared Traditional

K791064 - DUO TWO LAYER DENTURE CLEANSER

K791064 is an FDA 510(k) clearance for DUO TWO LAYER DENTURE CLEANSER, manufactured by Block Drug Company, Inc.. The device is a Class 1 Dental device with product code EFT cleared through the Traditional 510(k) pathway after a 120-day FDA review.

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

FDA 510(k) Submission Details - K791064

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.

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.