Cleared Traditional

K091964 - CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS

K091964 is an FDA 510(k) clearance for CREST GLIDE CLINICAL GUM PROTECTION DEN..., manufactured by Procter & Gamble Co.. The device is a Class 1 Dental device with product code JES cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K091964 · Procter & Gamble Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
85d
Days
Class 1
Risk

K091964 is an FDA 510(k) clearance for the CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS. Classified as Floss, Dental (product code JES), Class I - General Controls.

Submitted by Procter & Gamble Co. (Mason, US). The FDA issued a Cleared decision on September 24, 2009 after a review of 85 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 Procter & Gamble Co. devices

FDA 510(k) Submission Details - K091964

510(k) Number K091964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2009
Decision Date September 24, 2009
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
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: 127d · This submission: 85d
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 K091964.
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
DEN-MAT DENTAL FLOSSER
K791223 · Den-Mat Corp. · Oct 1979