Medical Device Manufacturer · CN , Rizhao City

Rizhao Huge Biomaterials Company, Ltd. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2020

Recent clearances: TopCEM Vigor SA Self-Adhesive Resin Cement, TempFIT Temporary Crown and Bridge Resin, HF-Etchant Hydrofluoric Acid Etching Gel

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Rizhao Huge Biomaterials Company, Ltd. Dental ✕

13 devices

1-13 of 13

Cleared Dec 12, 2025

TopCEM Vigor SA Self-Adhesive Resin Cement

Cleared Jun 23, 2025

TempFIT Temporary Crown and Bridge Resin

Cleared Dec 20, 2024

HF-Etchant Hydrofluoric Acid Etching Gel

Cleared Dec 20, 2024

TopCEM-Try in Veneer Try-in Gel

Cleared Nov 08, 2024

TopCEM Ceramic Primer Ceramic Coupling Agent

Cleared Jun 28, 2024

TopCEM-Veneer Light Cure Veneer Cement

Cleared Dec 22, 2023

TopCEM Dual Cure Resin Cement

Cleared Jul 25, 2023

Enamel Coating Resin

Cleared Oct 12, 2022

TrusFIL-Flow Flowable Composite Restorative

Cleared Sep 12, 2022

Phosphoric Acid Etching Gel

Cleared Oct 06, 2021

TrusFIL Universal Composite Restorative

Cleared Sep 29, 2020

Dual Cure Resin Cement

Cleared Sep 25, 2020

Light Cure Dental Adhesive