Cleared Traditional

Gradia Plus

K153325 · GC America, Inc. · Dental
Jul 2016
Decision
236d
Days
Class 2
Risk

About This 510(k) Submission

K153325 is an FDA 510(k) clearance for the Gradia Plus, 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 July 12, 2016, 236 days after receiving the submission on November 19, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K153325 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2015
Decision Date July 12, 2016
Days to Decision 236 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