Cleared Traditional

K040098 - VARNISHAMERICA

K040098 is the FDA 510(k) clearance for VARNISHAMERICA by Medical Products Laboratories, Inc.. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K040098 · Medical Products Laboratories, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
15d
Days
Class 2
Risk

K040098 is an FDA 510(k) clearance for the VARNISHAMERICA. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Medical Products Laboratories, Inc. (Philadelphia, US). The FDA issued a Cleared decision on February 4, 2004 after a review of 15 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 Medical Products Laboratories, Inc. devices

Submission Details

510(k) Number K040098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2004
Decision Date February 04, 2004
Days to Decision 15 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 127d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 79
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K040098.
ASCENT DENTAL CLEANSER
K070070 · CAO Group, Inc. · May 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
FLUORIDE VARNISH
K031932 · Dentsply Intl. · Sep 2003
CHLORAPREP
K021131 · Centrix, Inc. · Sep 2002