Cleared Traditional

ZRP

K131049 · Apex Dental Materials, Inc. · Dental
Aug 2013
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K131049 is an FDA 510(k) clearance for the ZRP, 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 August 27, 2013, 134 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 K131049 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2013
Decision Date August 27, 2013
Days to Decision 134 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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