Cleared Traditional

everX Posterior

K153127 · GC America, Inc. · Dental
May 2016
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K153127 is an FDA 510(k) clearance for the everX Posterior, 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 May 20, 2016, 204 days after receiving the submission on October 29, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K153127 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2015
Decision Date May 20, 2016
Days to Decision 204 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