Cleared Traditional

K061438 - ULTRAEZ DESENSITIZING GEL

K061438 is the FDA 510(k) clearance for ULTRAEZ DESENSITIZING GEL by Ultradent Products, Inc.. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 384-day FDA review.

K061438 · Ultradent Products, Inc. · Dental device
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Jun 2007
Decision
384d
Days
Class 2
Risk

K061438 is an FDA 510(k) clearance for the ULTRAEZ DESENSITIZING GEL. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on June 12, 2007 after a review of 384 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ultradent Products, Inc. devices

Submission Details

510(k) Number K061438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2006
Decision Date June 12, 2007
Days to Decision 384 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
257d slower than avg
Panel avg: 127d · This submission: 384d
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 70
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K061438.
FLOR-OPAL VARNISH WHITE
K080249 · Ultradent Products, Inc. · Feb 2008
SULTAN TOOTH ROOT DESENSITIZER
K072342 · Dentsply International, Inc. · Oct 2007
CERVITEC PLUS
K072338 · Ivoclar Vivadent, Inc. · Sep 2007
ENAMEL PRO VARNISH
K062683 · Premier Dental Products Co. · Nov 2006
FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502
K051750 · Ultradent Products, Inc. · Sep 2005
VIVASENS
K030922 · Ivoclar Vivadent, Inc. · Oct 2003