Cleared Traditional

K951917 - JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS

K951917 is an FDA 510(k) clearance for JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS, manufactured by Johnson & Johnson Consumer Products, Inc.. The device is a Class 1 Dental device with product code JES cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K951917 · Johnson & Johnson Consumer Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
16d
Days
Class 1
Risk

K951917 is an FDA 510(k) clearance for the JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS. Classified as Floss, Dental (product code JES), Class I - General Controls.

Submitted by Johnson & Johnson Consumer Products, Inc. (Skillman, US). The FDA issued a Cleared decision on May 10, 1995 after a review of 16 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.

View all Johnson & Johnson Consumer Products, Inc. devices

FDA 510(k) Submission Details - K951917

510(k) Number K951917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1995
Decision Date May 10, 1995
Days to Decision 16 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
111d faster than avg
Panel avg: 127d · This submission: 16d
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 K951917.
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