Cleared Traditional

FLOSSBRUSH WITH FLUORIDE (K964976) - FDA 510(k) Clearance

Class I Dental device.

K964976 · Flossbrush Interdental Cleaner and Applicator · Dental device
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May 1997
Decision
145d
Days
Class 1
Risk

K964976 is an FDA 510(k) clearance for the FLOSSBRUSH WITH FLUORIDE. Classified as Floss, Dental (product code JES), Class I - General Controls.

Submitted by Flossbrush Interdental Cleaner and Applicator (San Francisco, US). The FDA issued a Cleared decision on May 6, 1997 after a review of 145 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 Flossbrush Interdental Cleaner and Applicator devices

Submission Details

510(k) Number K964976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1996
Decision Date May 06, 1997
Days to Decision 145 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 127d · This submission: 145d
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.