Cleared Traditional

K061438 - ULTRAEZ DESENSITIZING GEL

K061438 is an FDA 510(k) clearance for ULTRAEZ DESENSITIZING GEL, manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K061438

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.

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 101
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
ASCENT DENTAL CLEANSER
K070070 · CAO Group, Inc. · May 2007
ENAMEL PRO VARNISH
K062683 · Premier Dental Products Co. · Nov 2006
MULTIPLE (TOOTH DESENSITIZER)
K052263 · Cosmedent, Inc. · Dec 2005