Cleared Traditional

DEN-MAT DENTAL FLOSSER (K791223) - FDA 510(k) Clearance

Class I Dental device.

K791223 · Den-Mat Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1979
Decision
98d
Days
Class 1
Risk

K791223 is an FDA 510(k) clearance for the DEN-MAT DENTAL FLOSSER. Classified as Floss, Dental (product code JES), Class I - General Controls.

Submitted by Den-Mat Corp. (Mchenry, US). The FDA issued a Cleared decision on October 9, 1979 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6390 - 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 Den-Mat Corp. devices

Submission Details

510(k) Number K791223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1979
Decision Date October 09, 1979
Days to Decision 98 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 127d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JES Floss, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6390
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.