Cleared Traditional

GC Fuji Triage EP

K193484 · GC America, Inc. · Dental
Jul 2020
Decision
198d
Days
Class 2
Risk

About This 510(k) Submission

K193484 is an FDA 510(k) clearance for the GC Fuji Triage EP, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on July 2, 2020, 198 days after receiving the submission on December 17, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K193484 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2019
Decision Date July 02, 2020
Days to Decision 198 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275