Cleared Traditional

K141422 - PROFLUORO FLUORIDE VARNISH

K141422 is an FDA 510(k) clearance for PROFLUORO FLUORIDE VARNISH, manufactured by Pac-Dent International, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K141422 · Pac-Dent International, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
123d
Days
Class 2
Risk

K141422 is an FDA 510(k) clearance for the PROFLUORO FLUORIDE VARNISH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Pac-Dent International, Inc. (Walnut, US). The FDA issued a Cleared decision on September 30, 2014 after a review of 123 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K141422

510(k) Number K141422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2014
Decision Date September 30, 2014
Days to Decision 123 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
5d faster than avg
Panel avg: 128d · This submission: 123d
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 126
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K141422.
LISTERINE Sensitivity Defense Mouthrinse
K143155 · Johnson & Johnson Healthcare Products, Division of Mcneil-Pp · Jan 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
STARBRIGHT 5% SODIUM FLUORIDE VARNISH
K140349 · Nanova Biomaterials, Inc. · Sep 2014
COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH
K140481 · Colgate-Palmolive Company · Jun 2014
SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS
K132426 · Sylphar N.V. · Feb 2014