Cleared Traditional

K021131 - CHLORAPREP

K021131 is an FDA 510(k) clearance for CHLORAPREP, manufactured by Centrix, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K021131 · Centrix, Inc. · Dental device
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Sep 2002
Decision
171d
Days
Class 2
Risk

K021131 is an FDA 510(k) clearance for the CHLORAPREP. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on September 26, 2002 after a review of 171 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Centrix, Inc. devices

FDA 510(k) Submission Details - K021131

510(k) Number K021131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2002
Decision Date September 26, 2002
Days to Decision 171 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 127d · This submission: 171d
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 K021131.
PROTECT TOOTH DESENSITIZER
K050486 · Sunstar Butler · Jun 2005
VIVASENS
K030922 · Ivoclar Vivadent, Inc. · Oct 2003
FLUORIDE VARNISH
K031932 · Dentsply Intl. · Sep 2003
SEAL & PROTECT PROTECTIVE SEALANT
K021805 · Dentsply Intl. · Aug 2002
PULPDENT CAVITY PREPARATION IV
K013411 · Pulpdent Corp. · Dec 2001
QUELL DESENSITIZER
K010957 · Jeneric/Pentron, Inc. · Jun 2001