Cleared Traditional

ORAL-B DENTAL FLOSS WITH FLUORIDE (K925409) - FDA 510(k) Clearance

Class I Dental device.

K925409 · Oral-B Laboratories · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
94d
Days
Class 1
Risk

K925409 is an FDA 510(k) clearance for the ORAL-B DENTAL FLOSS WITH FLUORIDE. Classified as Floss, Dental (product code JES), Class I - General Controls.

Submitted by Oral-B Laboratories (Redwood City, US). The FDA issued a Cleared decision on January 28, 1993 after a review of 94 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.

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Submission Details

510(k) Number K925409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1992
Decision Date January 28, 1993
Days to Decision 94 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 127d · This submission: 94d
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.