Cleared Traditional

OPTIGLAZE COLOR

K133836 · GC America, Inc. · Dental
Mar 2014
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K133836 is an FDA 510(k) clearance for the OPTIGLAZE COLOR, a Coating, Filling Material, Resin (Class II — Special Controls, product code EBD), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on March 6, 2014, 78 days after receiving the submission on December 18, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3310.

Submission Details

510(k) Number K133836 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2013
Decision Date March 06, 2014
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBD — Coating, Filling Material, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3310

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