Cleared Traditional

METAL OPAQUER

K110859 · Apex Dental Materials, Inc. · Dental
Jun 2011
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K110859 is an FDA 510(k) clearance for the METAL OPAQUER, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Apex Dental Materials, Inc. (Lake Zurich, US). The FDA issued a Cleared decision on June 23, 2011, 87 days after receiving the submission on March 28, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K110859 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2011
Decision Date June 23, 2011
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690