Cleared Special

AQUEOUS ACRYLIC DISPERSION 28% W/W (K023671) - FDA 510(k) Clearance

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

K023671 · Chx Technologies, Inc. · Dental device
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Nov 2002
Decision
24d
Days
Class 2
Risk

K023671 is an FDA 510(k) clearance for the AQUEOUS ACRYLIC DISPERSION 28% W/W. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Chx Technologies, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on November 25, 2002 after a review of 24 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 Chx Technologies, Inc. devices

Submission Details

510(k) Number K023671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2002
Decision Date November 25, 2002
Days to Decision 24 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 127d · This submission: 24d
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 28
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K023671.
Clinpro Varnish
K151302 · 3M Company · Sep 2015
VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
K090519 · 3M Company · Apr 2009
FLUORIDE VARNISH
K031932 · Dentsply Intl. · Sep 2003
SEAL & PROTECT PROTECTIVE SEALANT
K021805 · Dentsply Intl. · Aug 2002
SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE
K992822 · Dentsply Intl. · Nov 1999
ACA THYROXINE ANALYTICAL TEST PACK
K833701 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1984