Rizhao Huge Biomaterials Company, Ltd.

ChinaFDA applicant, unverified FDA FEI 3017674095

Devices: 73
Registrations: FDA
FDA recalls: 0

What Rizhao Huge Biomaterials Company, Ltd. makes

The company manufactures dental materials for restorative and adhesive procedures, including light-cure and dual-cure resin cements, flowable and universal composite restoratives, dentine bonding agents, and temporary crown-and-bridge resins. Their portfolio also includes ceramic primers, coupling agents, and try-in gels for veneers.

These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. The company operates from the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue73

Newest first, rows 51-73 of 73

Search and filter all 73 devices

Dual Cure Resin Cement Automix

None Registry: GUDID Class:II
TrusFIL-Flow Flowable Composite Restorative B1-2g

Withdrawn Registry: GUDID Class:II
Dual Cure Resin Cement Automix

None Registry: GUDID Class:II
Dual Cure Resin Cement Automix

Withdrawn Registry: GUDID Class:II
Dual Cure Resin Cement Automix

None Registry: GUDID Class:II
TrusFIL Universal Composite Restorative B1-4g

Withdrawn Registry: GUDID Class:II
TrusFIL-Flow Flowable Composite Restorative A1-2g

Withdrawn Registry: GUDID Class:II
Dual Cure Resin Cement Automix

None Registry: GUDID Class:II
Dual Cure Resin Cement Automix

None Registry: GUDID Class:II
Ceramic Coupling Agent 5ml

Withdrawn Registry: GUDID Class:II
TopCEM Ceramic Primer Ceramic Coupling Agent Ref K242749

Active Regimes: 510(k) Registry: 510(k) Class:II
TempFIT Temporary Crown and Bridge Resin Ref K251271

Active Regimes: 510(k) Registry: 510(k) Class:II
TrusFIL-Flow Flowable Composite Restorative Ref K221510

Active Regimes: 510(k) Registry: 510(k) Class:II
TopCEM-Try in Veneer Try-in Gel Ref K242572

Active Regimes: 510(k) Registry: 510(k) Class:II
TrusFIL Universal Composite Restorative Ref K202063

Active Regimes: 510(k) Registry: 510(k) Class:II
Light Cure Dental Adhesive Ref K201787

Active Regimes: 510(k) Registry: 510(k) Class:II
Enamel Coating Resin Ref K230455

Active Regimes: 510(k) Registry: 510(k) Class:II
TopCEM Dual Cure Resin Cement Ref K233082

Active Regimes: 510(k) Registry: 510(k) Class:II
Dual Cure Resin Cement Ref K201790

Active Regimes: 510(k) Registry: 510(k) Class:II
Phosphoric Acid Etching Gel Ref K221450

Active Regimes: 510(k) Registry: 510(k) Class:II
TopCEM-Veneer Light Cure Veneer Cement Ref K241204

Active Regimes: 510(k) Registry: 510(k) Class:II
HF-Etchant Hydrofluoric Acid Etching Gel Ref K242530

Active Regimes: 510(k) Registry: 510(k) Class:II
TopCEM Vigor SA Self-Adhesive Resin Cement Ref K252785

Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 51-73 of 73

Showing 51-73 of 73

Company details

FDA FEI number: 3017674095
DUNS number: 544452689
Address: No.2 North Zhaoyang Road, District of Donggang, Rizhao Shandong

What Rizhao Huge Biomaterials Company, Ltd. makes

Catalogue73

TopCEM Ceramic Primer Ceramic Coupling Agent Ref K242749

TempFIT Temporary Crown and Bridge Resin Ref K251271

TrusFIL-Flow Flowable Composite Restorative Ref K221510

TopCEM-Try in Veneer Try-in Gel Ref K242572

TrusFIL Universal Composite Restorative Ref K202063

Light Cure Dental Adhesive Ref K201787

Enamel Coating Resin Ref K230455

TopCEM Dual Cure Resin Cement Ref K233082

Dual Cure Resin Cement Ref K201790

Phosphoric Acid Etching Gel Ref K221450

TopCEM-Veneer Light Cure Veneer Cement Ref K241204

HF-Etchant Hydrofluoric Acid Etching Gel Ref K242530

TopCEM Vigor SA Self-Adhesive Resin Cement Ref K252785

Company details