Cleared Traditional

Glass Ionomer Cement

K160345 · Shandong Huge Dental Material Corporation · Dental
Mar 2017
Decision
389d
Days
Class 2
Risk

About This 510(k) Submission

K160345 is an FDA 510(k) clearance for the Glass Ionomer Cement, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Shandong Huge Dental Material Corporation (Rizhao City, CN). The FDA issued a Cleared decision on March 3, 2017, 389 days after receiving the submission on February 8, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K160345 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2016
Decision Date March 03, 2017
Days to Decision 389 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275