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)
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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.

View all Pac-Dent International, Inc. devices

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
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 127d · 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 83
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K141422.
V-varnish Premium
K160377 · Vericom Co., Ltd. · Dec 2016
Clinpro Varnish
K151302 · 3M Company · Sep 2015
FLUOR PROTECTOR S
K131487 · Ivoclar Vivadent, AG · Oct 2014
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
K123653 · Bisco, Inc. · Jun 2013
PRG BARRIER COAT
K122908 · Shofu Dental Corporation · Apr 2013
CAVITY VARNISH
K122331 · Dentsply International, Inc. · Oct 2012