Cleared Traditional

K944034 - PERIO-MED DENTAL FLOSS

K944034 is an FDA 510(k) clearance for PERIO-MED DENTAL FLOSS, 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 357-day FDA review.

K944034 · Whitehill Oral Technologies, Inc. · Dental device
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Jul 1995
Decision
357d
Days
Class 1
Risk

K944034 is an FDA 510(k) clearance for the PERIO-MED DENTAL FLOSS. 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 July 25, 1995 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Whitehill Oral Technologies, Inc. devices

FDA 510(k) Submission Details - K944034

510(k) Number K944034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1994
Decision Date July 25, 1995
Days to Decision 357 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
230d slower than avg
Panel avg: 127d · This submission: 357d
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 7
Devices cleared under the same product code (JES) and FDA review panel - the closest regulatory comparables to K944034.
CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
K091964 · Procter & Gamble Co. · Sep 2009
FLOSSBRUSH WITH FLUORIDE
K964976 · Flossbrush Interdental Cleaner and Applicator · May 1997
IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID
K963746 · Whitehill Oral Technologies, Inc. · Dec 1996
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