Cleared Traditional

G-Premio BOND

K143140 · GC America, Inc. · Dental
Apr 2015
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K143140 is an FDA 510(k) clearance for the G-Premio BOND, 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 April 20, 2015, 168 days after receiving the submission on November 3, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K143140 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2014
Decision Date April 20, 2015
Days to Decision 168 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