Cleared Traditional

G-CEM ONE

K200798 · GC America, Inc. · Dental
Nov 2020
Decision
243d
Days
Class 2
Risk

About This 510(k) Submission

K200798 is an FDA 510(k) clearance for the G-CEM ONE, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on November 24, 2020, 243 days after receiving the submission on March 26, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K200798 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2020
Decision Date November 24, 2020
Days to Decision 243 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