Glass Ionomer Cement (Luting)
K-Number: K161851 · 2016-10-31
Decision Date2016-10-31
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Glass Ionomer Cement (Luting) is a medical device manufactured by Shandong Huge Dental Material Corporation. It received FDA 510(k) clearance on 2016-10-31 under approval number K161851. 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 (Luting)?
Glass Ionomer Cement (Luting) is a medical device that received FDA 510(k) clearance on 2016-10-31. It is manufactured by Shandong Huge Dental Material Corporation. The 510(k) number is K161851.
When was Glass Ionomer Cement (Luting) approved by the FDA?
Glass Ionomer Cement (Luting) received FDA 510(k) clearance on 2016-10-31, under approval number K161851.
What company makes Glass Ionomer Cement (Luting)?
Glass Ionomer Cement (Luting) is manufactured by Shandong Huge Dental Material Corporation.
What is the FDA product code for Glass Ionomer Cement (Luting)?
The FDA product code for Glass Ionomer Cement (Luting) 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.