Cleared Traditional

BENDA WEDGE

K140144 · Centrix, Inc. · Dental
Jul 2014
Decision
167d
Days
Class 1
Risk

About This 510(k) Submission

K140144 is an FDA 510(k) clearance for the BENDA WEDGE, a Handle, Instrument, Dental (Class I — General Controls, product code EJB), submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on July 8, 2014, 167 days after receiving the submission on January 22, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K140144 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2014
Decision Date July 08, 2014
Days to Decision 167 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EJB — Handle, Instrument, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565