Cleared Traditional

SENZZZZZ AWAY

K120176 · Centrix, Inc. · Dental
Jul 2012
Decision
187d
Days
Class 2
Risk

About This 510(k) Submission

K120176 is an FDA 510(k) clearance for the SENZZZZZ AWAY, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Centrix, Inc. (San Diego, US). The FDA issued a Cleared decision on July 25, 2012, 187 days after receiving the submission on January 20, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K120176 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2012
Decision Date July 25, 2012
Days to Decision 187 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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

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