Cleared Traditional

GC Fuji Direct

K172382 · GC America, Inc. · Dental
Apr 2018
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K172382 is an FDA 510(k) clearance for the GC Fuji Direct, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on April 2, 2018, 237 days after receiving the submission on August 8, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K172382 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2017
Decision Date April 02, 2018
Days to Decision 237 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