Cleared Traditional

K051750 - FLOR-OPAL VARNISH

K051750 is the FDA 510(k) clearance for FLOR-OPAL VARNISH by Ultradent Products, Inc.. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K051750 · Ultradent Products, Inc. · Dental device
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Sep 2005
Decision
82d
Days
Class 2
Risk

K051750 is an FDA 510(k) clearance for the FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502. 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 September 19, 2005 after a review of 82 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 Ultradent Products, Inc. devices

Submission Details

510(k) Number K051750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2005
Decision Date September 19, 2005
Days to Decision 82 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 127d · This submission: 82d
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 K051750.
CERVITEC PLUS
K072338 · Ivoclar Vivadent, Inc. · Sep 2007
ULTRAEZ DESENSITIZING GEL
K061438 · Ultradent Products, Inc. · Jun 2007
ENAMEL PRO VARNISH
K062683 · Premier Dental Products Co. · Nov 2006
VIVASENS
K030922 · Ivoclar Vivadent, Inc. · Oct 2003
FLUORIDE VARNISH
K031932 · Dentsply Intl. · Sep 2003
CHLORAPREP
K021131 · Centrix, Inc. · Sep 2002