Cleared Abbreviated

K113146 - PCXX VARNISH

K113146 is an FDA 510(k) clearance for PCXX VARNISH, manufactured by Ross Healthcare, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Abbreviated 510(k) pathway after a 91-day FDA review.

K113146 · Ross Healthcare, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
91d
Days
Class 2
Risk

K113146 is an FDA 510(k) clearance for the PCXX VARNISH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Ross Healthcare, Inc. (Blaine, US). The FDA issued a Cleared decision on January 23, 2012 after a review of 91 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ross Healthcare, Inc. devices

FDA 510(k) Submission Details - K113146

510(k) Number K113146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2011
Decision Date January 23, 2012
Days to Decision 91 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Standards-based clearance path.

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 81
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K113146.
PRG BARRIER COAT
K122908 · Shofu Dental Corporation · Apr 2013
CAVITY VARNISH
K122331 · Dentsply International, Inc. · Oct 2012
SENZZZZZ AWAY
K120176 · Centrix, Inc. · Jul 2012
ACTIV VARNISH
K112946 · Pulpdent Corporation · Dec 2011
NUPRO MODEL 13016901
K103160 · CAO Group, Inc. · Jan 2011
MI VARNISH
K102808 · GC America, Inc. · Dec 2010