Cleared Traditional

APEX UNIVERSAL ADHESIVE

K131043 · Apex Dental Materials, Inc. · Dental
Sep 2013
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K131043 is an FDA 510(k) clearance for the APEX UNIVERSAL ADHESIVE, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Apex Dental Materials, Inc. (Lake Zurich, US). The FDA issued a Cleared decision on September 10, 2013, 148 days after receiving the submission on April 15, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K131043 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2013
Decision Date September 10, 2013
Days to Decision 148 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200