Cleared Traditional

MSN-006

K141562 · GC America, Inc. · Dental
Sep 2014
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K141562 is an FDA 510(k) clearance for the MSN-006, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on September 5, 2014, 85 days after receiving the submission on June 12, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K141562 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2014
Decision Date September 05, 2014
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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