Cleared Special

K080249 - FLOR-OPAL VARNISH WHITE

Also marketed or referenced as:
MODELS 4503, 4504, 4506, S4505

K080249 is the FDA 510(k) clearance for FLOR-OPAL VARNISH WHITE by Ultradent Products, Inc.. It is a Class 2 Dental device (product code LBH) cleared through the Special 510(k) pathway after a 8-day FDA review.

K080249 · Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
8d
Days
Class 2
Risk

K080249 is an FDA 510(k) clearance for the FLOR-OPAL VARNISH WHITE. 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 February 8, 2008 after a review of 8 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ultradent Products, Inc. devices

Submission Details

510(k) Number K080249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2008
Decision Date February 08, 2008
Days to Decision 8 days
Submission Type Special
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
119d faster than avg
Panel avg: 127d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

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 K080249.
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
VOCO PROFLUORID VARNISH
K080814 · Voco GmbH · Jul 2008
SULTAN TOOTH ROOT DESENSITIZER
K072342 · Dentsply International, Inc. · Oct 2007
CERVITEC PLUS
K072338 · Ivoclar Vivadent, Inc. · Sep 2007
ULTRAEZ DESENSITIZING GEL
K061438 · Ultradent Products, Inc. · Jun 2007