Cleared Traditional

K963746 - IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID

K963746 is an FDA 510(k) clearance for IDS DENTAL FLOSS WITH SODIUM FLUORIDE M..., manufactured by Whitehill Oral Technologies, Inc.. The device is a Class 1 Dental device with product code JES cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K963746 · Whitehill Oral Technologies, Inc. · Dental device
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Dec 1996
Decision
86d
Days
Class 1
Risk

K963746 is an FDA 510(k) clearance for the IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUO.... Classified as Floss, Dental (product code JES), Class I - General Controls.

Submitted by Whitehill Oral Technologies, Inc. (Hazlet, US). The FDA issued a Cleared decision on December 12, 1996 after a review of 86 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K963746

510(k) Number K963746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1996
Decision Date December 12, 1996
Days to Decision 86 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
42d faster than avg
Panel avg: 128d · This submission: 86d
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

All 43
Devices cleared under the same product code (JES) and FDA review panel - the closest regulatory comparables to K963746.
CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
K091964 · Procter & Gamble Co. · Sep 2009
FLOSSBRUSH WITH FLUORIDE
K964976 · Flossbrush Interdental Cleaner and Applicator · May 1997
PERIO-MED DENTAL FLOSS
K944034 · Whitehill Oral Technologies, Inc. · Jul 1995
VUTLER G.U.M. WITH FLUORIDE
K952091 · John O. Butler Co. · Jun 1995
JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS
K951917 · Johnson & Johnson Consumer Products, Inc. · May 1995
RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE
K942689 · Ranir/Dcp Corp. · Apr 1995
K963746 · IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID
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