Cleared Traditional

K143155 - LISTERINE Sensitivity Defense Mouthrinse

K143155 is an FDA 510(k) clearance for LISTERINE Sensitivity Defense Mouthrinse, manufactured by Johnson & Johnson Healthcare Products, Division of Mcneil-Pp. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K143155 · Johnson & Johnson Healthcare Products, Division of Mcneil-Pp · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
87d
Days
Class 2
Risk

K143155 is an FDA 510(k) clearance for the LISTERINE Sensitivity Defense Mouthrinse. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Johnson & Johnson Healthcare Products, Division of Mcneil-Pp (Skillman, US). The FDA issued a Cleared decision on January 29, 2015 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - 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 Healthcare Products, Division of Mcneil-Pp devices

FDA 510(k) Submission Details - K143155

510(k) Number K143155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2014
Decision Date January 29, 2015
Days to Decision 87 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
41d faster than avg
Panel avg: 128d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBH Device Classification - Class 2, Special Controls

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - LBH Varnish, Cavity

All 120
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K143155.
V-varnish Premium
K160377 · Vericom Co., Ltd. · Dec 2016
Oral-B 5% Sodium Fluoride Varnish
K153334 · Young Dental Manufacturing Co. 1, LLC · May 2016
Clinpro Varnish
K151302 · 3M Company · Sep 2015
VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL
K140350 · Preventive Technologies, Inc. · Dec 2014
FLUOR PROTECTOR S
K131487 · Ivoclar Vivadent, AG · Oct 2014
PROFLUORO FLUORIDE VARNISH
K141422 · Pac-Dent International, Inc. · Sep 2014