Cleared Traditional

GC Acrylic Primer

K180917 · GC America, Inc. · Dental
Nov 2018
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K180917 is an FDA 510(k) clearance for the GC Acrylic Primer, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on November 20, 2018, 225 days after receiving the submission on April 9, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K180917 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2018
Decision Date November 20, 2018
Days to Decision 225 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200