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FDA 510(k)

TopCEM Dual Cure Resin Cement

K-Number: K233082 · 2023-12-22

ApplicantRizhao Huge Biomaterials Company, Ltd.
Decision Date2023-12-22
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TopCEM Dual Cure Resin Cement is a medical device manufactured by Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2023-12-22 under approval number K233082. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TopCEM Dual Cure Resin Cement?

TopCEM Dual Cure Resin Cement is a medical device that received FDA 510(k) clearance on 2023-12-22. It is manufactured by Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K233082.

When was TopCEM Dual Cure Resin Cement approved by the FDA?

TopCEM Dual Cure Resin Cement received FDA 510(k) clearance on 2023-12-22, under approval number K233082.

What company makes TopCEM Dual Cure Resin Cement?

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

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

The FDA product code for TopCEM Dual Cure Resin Cement is EBF.

Related Clinical Trials

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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 K230455Enamel Coating Resin

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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.

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