Cleared Traditional

HTFX-222

K133182 · GC America, Inc. · Dental
Apr 2014
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K133182 is an FDA 510(k) clearance for the HTFX-222, 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 April 9, 2014, 174 days after receiving the submission on October 17, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K133182 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2013
Decision Date April 09, 2014
Days to Decision 174 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