Rizhao Huge Biomaterials Company, Ltd. FDA Approvals

0 new drug approvals and 11 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
TopCEM Vigor SA Self-Adhesive Resin Cement510(k)Dec 12, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 12, 2025
TempFIT Temporary Crown and Bridge Resin510(k)Jun 23, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jun 23, 2025
HF-Etchant Hydrofluoric Acid Etching Gel510(k)Dec 20, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 20, 2024
TopCEM-Try in Veneer Try-in Gel510(k)Dec 20, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 20, 2024
TopCEM Ceramic Primer Ceramic Coupling Agent510(k)Nov 8, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Nov 8, 2024
TopCEM-Veneer Light Cure Veneer Cement510(k)Jun 28, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jun 28, 2024
TopCEM Dual Cure Resin Cement510(k)Dec 22, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 22, 2023
Enamel Coating Resin510(k)Jul 25, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 25, 2023
TrusFIL-Flow Flowable Composite Restorative510(k)Oct 12, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 12, 2022
Phosphoric Acid Etching Gel510(k)Sep 12, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 12, 2022
TrusFIL Universal Composite Restorative510(k)Oct 6, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 6, 2021