Cleared Special

FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH (K090597) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K090597 · Pascal Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
11d
Days
Class 2
Risk

K090597 is an FDA 510(k) clearance for the FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Pascal Co., Inc. (Bellevue, US). The FDA issued a Cleared decision on March 16, 2009 after a review of 11 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 Pascal Co., Inc. devices

Submission Details

510(k) Number K090597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2009
Decision Date March 16, 2009
Days to Decision 11 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 127d · This submission: 11d
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 136
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K090597.
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K241489 · Inter-Med, Inc. · Jan 2025