Glass Ionomer Cement— 510(k) K160345

Name: FDA 510(k) clearance K160345
Creator: U.S. Food and Drug Administration
Published: 2017-03-03

Substantially Equivalent

Shandong Huge Dental Material Corporation

FDA 510(k) clearance K160345 for Glass Ionomer Cement, Substantially Equivalent on 2017-03-03. Applicant: Shandong Huge Dental Material Corporation. Device class: 2.

Clearance details

Applicant: Shandong Huge Dental Material Corporation
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2016-02-08
Decision date: 2017-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rizhao City, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.