Cleared Traditional

G-Fix

K151541 · GC America, Inc. · Dental
Oct 2015
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K151541 is an FDA 510(k) clearance for the G-Fix, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on October 9, 2015, 123 days after receiving the submission on June 8, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K151541 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 2015
Decision Date October 09, 2015
Days to Decision 123 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690