Cleared Traditional

GC Temp Print

K193113 · GC America, Inc. · Dental
Jul 2020
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K193113 is an FDA 510(k) clearance for the GC Temp Print, 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 July 9, 2020, 240 days after receiving the submission on November 12, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K193113 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2019
Decision Date July 09, 2020
Days to Decision 240 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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