Cleared Traditional

K964976 - FLOSSBRUSH WITH FLUORIDE

K964976 is an FDA 510(k) clearance for FLOSSBRUSH WITH FLUORIDE, manufactured by Flossbrush Interdental Cleaner and Applicator. The device is a Class 1 Dental device with product code JES cleared through the Traditional 510(k) pathway after a 145-day FDA review.

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

FDA 510(k) Submission Details - K964976

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 127d · This submission: 145d
Pathway characteristics
Predicate-based equivalence.

JES Device Classification - Class 1, General Controls

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.

Regulatory Peers - JES Floss, Dental

Devices cleared under the same product code (JES) and FDA review panel - the closest regulatory comparables to K964976.
CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
K091964 · Procter & Gamble Co. · Sep 2009
ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE
K921601 · Ultradent Products, Inc. · Jun 1992
G-FLOSS & G-FLOSS II
K911701 · Implant Innovations International, Inc. · May 1991
RETRACT-A-CORD
K854701 · Almore Intl., Inc. · Mar 1986
DEN-MAT DENTAL FLOSSER
K791223 · Den-Mat Corp. · Oct 1979