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FDA 510(k)

TopCEM-Veneer Light Cure Veneer Cement

K-Number: K241204 · 2024-06-28

ApplicantRizhao Huge Biomaterials Company, Ltd.
Decision Date2024-06-28
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TopCEM-Veneer Light Cure Veneer Cement is a medical device manufactured by Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2024-06-28 under approval number K241204. 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 TopCEM-Veneer Light Cure Veneer Cement?

TopCEM-Veneer Light Cure Veneer Cement is a medical device that received FDA 510(k) clearance on 2024-06-28. It is manufactured by Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K241204.

When was TopCEM-Veneer Light Cure Veneer Cement approved by the FDA?

TopCEM-Veneer Light Cure Veneer Cement received FDA 510(k) clearance on 2024-06-28, under approval number K241204.

What company makes TopCEM-Veneer Light Cure Veneer Cement?

TopCEM-Veneer Light Cure Veneer Cement is manufactured by Rizhao Huge Biomaterials Company, Ltd..

What is the FDA product code for TopCEM-Veneer Light Cure Veneer Cement?

The FDA product code for TopCEM-Veneer Light Cure Veneer Cement is EMA.

Related Clinical Trials

NCT07504393 Clinical Performance of Four Restorative Materials in Primary Molars NOT_YET_RECRUITING

Other Devices by Rizhao Huge Biomaterials Company, Ltd.

K201790Dual Cure Resin Cement K201787Light Cure Dental Adhesive K202063TrusFIL Universal Composite Restorative K221510TrusFIL-Flow Flowable Composite Restorative K221450Phosphoric Acid Etching Gel K233082TopCEM Dual Cure Resin Cement

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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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