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FDA 510(k)

Dual Cure Resin Cement

K-Number: K201790 · 2020-09-29

ApplicantRizhao Huge Biomaterials Company, Ltd.
Decision Date2020-09-29
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dual Cure Resin Cement is a medical device manufactured by Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2020-09-29 under approval number K201790. 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 Dual Cure Resin Cement?

Dual Cure Resin Cement is a medical device that received FDA 510(k) clearance on 2020-09-29. It is manufactured by Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K201790.

When was Dual Cure Resin Cement approved by the FDA?

Dual Cure Resin Cement received FDA 510(k) clearance on 2020-09-29, under approval number K201790.

What company makes Dual Cure Resin Cement?

Dual Cure Resin Cement is manufactured by Rizhao Huge Biomaterials Company, Ltd..

What is the FDA product code for Dual Cure Resin Cement?

The FDA product code for Dual Cure Resin Cement is EMA.

Related Clinical Trials

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Other Devices by Rizhao Huge Biomaterials Company, Ltd.

K201787Light Cure Dental Adhesive K202063TrusFIL Universal Composite Restorative K221510TrusFIL-Flow Flowable Composite Restorative K221450Phosphoric Acid Etching Gel K233082TopCEM Dual Cure Resin Cement K230455Enamel Coating Resin

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Related Devices (Code: EMA)

K160800DuoCemColtene/Whaledent AG K161851Glass Ionomer Cement (Luting)Shandong Huge Dental Material Corporation K160443TempoCem ClearDmg USA, Inc. K160774IonoStar PlusVoco GmbH K161256TheraCemBisco, Inc. K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.

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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