Cleared Traditional

G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer

K153231 · GC America, Inc. · Dental
Jul 2016
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K153231 is an FDA 510(k) clearance for the G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer, 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 6, 2016, 240 days after receiving the submission on November 9, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K153231 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2015
Decision Date July 06, 2016
Days to Decision 240 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