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FDA 510(k)

Glass Ionomer Cement (Luting)

K-Number: K161851 · 2016-10-31

ApplicantShandong Huge Dental Material Corporation
Decision Date2016-10-31
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Glass Ionomer Cement (Luting) is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Huge Dental Material Corporation. It received FDA 510(k) clearance on 2016-10-31 under 510(k) 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. The listed applicant is Shandong Huge Dental Material Corporation. The 510(k) number is K161851.

When did Glass Ionomer Cement (Luting) receive FDA 510(k) clearance?

Glass Ionomer Cement (Luting) received FDA 510(k) clearance on 2016-10-31, under 510(k) number K161851.

Who is the listed applicant for Glass Ionomer Cement (Luting)?

The FDA 510(k) record lists Shandong Huge Dental Material Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Glass Ionomer Cement (Luting)?

The FDA product code for Glass Ionomer Cement (Luting) is EMA.

Related Clinical Trials

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Other records listing Shandong Huge Dental Material Corporation as applicant

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Related Devices (Code: EMA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbHK254063iCEM Universal PlusKulzer, LLCK252785TopCEM Vigor SA Self-Adhesive Resin CementRizhao Huge Biomaterials Company, Ltd.

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.

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