Cleared Traditional

K021131 - CHLORAPREP (FDA 510(k) Clearance)

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

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

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on September 26, 2002, 171 days after receiving the submission on April 8, 2002.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.

Submission Details

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

Device Classification

Product Code LBH — Varnish, Cavity
Device Class Class II - Special Controls
CFR Regulation 21 CFR 872.3260