Cleared Traditional

GC FujiCEM 2 (Improved)

K182854 · GC America, Inc. · Dental
Jul 2019
Decision
274d
Days
Class 2
Risk

About This 510(k) Submission

K182854 is an FDA 510(k) clearance for the GC FujiCEM 2 (Improved), 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 11, 2019, 274 days after receiving the submission on October 10, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K182854 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2018
Decision Date July 11, 2019
Days to Decision 274 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