Cleared Traditional

K112946 - ACTIV VARNISH

K112946 is the FDA 510(k) clearance for ACTIV VARNISH by Pulpdent Corporation. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K112946 · Pulpdent Corporation · Dental device
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Optimized for regulatory review, auditing and printing
Dec 2011
Decision
66d
Days
Class 2
Risk

K112946 is an FDA 510(k) clearance for the ACTIV VARNISH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on December 9, 2011 after a review of 66 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 Pulpdent Corporation devices

Submission Details

510(k) Number K112946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2011
Decision Date December 09, 2011
Days to Decision 66 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
61d faster than avg
Panel avg: 127d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 71
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K112946.
PRG BARRIER COAT
K122908 · Shofu Dental Corporation · Apr 2013
CAVITY VARNISH
K122331 · Dentsply International, Inc. · Oct 2012
SENZZZZZ AWAY
K120176 · Centrix, Inc. · Jul 2012
MI VARNISH
K102808 · GC America, Inc. · Dec 2010
VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
K090519 · 3M Company · Apr 2009
VOCO PROFLUORID L
K083036 · Voco GmbH · Jan 2009