Cleared Special

K090519 - VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247

K090519 is an FDA 510(k) clearance for VANISH VARNISH, manufactured by 3M Company. The device is a Class 2 Dental device with product code LBH cleared through the Special 510(k) pathway after a 48-day FDA review.

K090519 · 3M Company · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
48d
Days
Class 2
Risk

K090519 is an FDA 510(k) clearance for the VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% F.... Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by 3M Company (St Paul, US). The FDA issued a Cleared decision on April 15, 2009 after a review of 48 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.

FDA 510(k) Submission Details - K090519

510(k) Number K090519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2009
Decision Date April 15, 2009
Days to Decision 48 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
80d faster than avg
Panel avg: 128d · This submission: 48d
Pathway characteristics
Modification to existing cleared device.

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 133
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K090519.
VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH
K092141 · 3M Espe Dental Products · Mar 2010
PULPDENT FLUORIDE VARNISH
K093620 · Pulpdent Corporation · Mar 2010
GLUMA DESENSITIZER POWER GEL
K093575 · Heraeus Kulzer, LLC · Mar 2010
REMESENSE
K082594 · Remedent NV · Mar 2009
FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH
K090597 · Pascal Co., Inc. · Mar 2009
VOCO PROFLUORID L
K083036 · Voco GmbH · Jan 2009
K090519 · VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
Download PDF FDA Summary 3M Company