Glass Ionomer Cement
K-Number: K160345 · 2017-03-03
Decision Date2017-03-03
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Glass Ionomer Cement is a medical device manufactured by Shandong Huge Dental Material Corporation. It received FDA 510(k) clearance on 2017-03-03 under approval number K160345. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Glass Ionomer Cement?
Glass Ionomer Cement is a medical device that received FDA 510(k) clearance on 2017-03-03. It is manufactured by Shandong Huge Dental Material Corporation. The 510(k) number is K160345.
When was Glass Ionomer Cement approved by the FDA?
Glass Ionomer Cement received FDA 510(k) clearance on 2017-03-03, under approval number K160345.
What company makes Glass Ionomer Cement?
Glass Ionomer Cement is manufactured by Shandong Huge Dental Material Corporation.
What is the FDA product code for Glass Ionomer Cement?
The FDA product code for Glass Ionomer Cement is EMA.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.