Cleared Traditional

NMF004A

K173500 · GC America, Inc. · Dental
Mar 2018
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K173500 is an FDA 510(k) clearance for the NMF004A, 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 March 8, 2018, 115 days after receiving the submission on November 13, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K173500 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2017
Decision Date March 08, 2018
Days to Decision 115 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