Cleared Traditional

everX Flow

K192260 · GC America, Inc. · Dental
Nov 2019
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K192260 is an FDA 510(k) clearance for the everX Flow, 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 November 22, 2019, 93 days after receiving the submission on August 21, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K192260 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2019
Decision Date November 22, 2019
Days to Decision 93 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