Cleared Traditional

RnD TE and RnD SE

K161077 · Apex Dental Materials, Inc. · Dental
Mar 2017
Decision
333d
Days
Class 2
Risk

About This 510(k) Submission

K161077 is an FDA 510(k) clearance for the RnD TE and RnD SE, 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 March 17, 2017, 333 days after receiving the submission on April 18, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K161077 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2016
Decision Date March 17, 2017
Days to Decision 333 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