Cleared Traditional

K051750 - FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502

K051750 is an FDA 510(k) clearance for FLOR-OPAL VARNISH, 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 82-day FDA review.

K051750 · Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K051750

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.

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 K051750.
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
PROTECT TOOTH DESENSITIZER
K050486 · Sunstar Butler · Jun 2005
VIVASENS
K030922 · Ivoclar Vivadent, Inc. · Oct 2003
FLUORIDE VARNISH
K031932 · Dentsply Intl. · Sep 2003