Data / Medical devices / China / Rizhao Huge Biomaterials Company, Ltd.
Rizhao Huge Biomaterials Company, Ltd.: FDA-registered device maker in Rizhao Shandong, China, 13 510(k) clearances
Rizhao Huge Biomaterials Company, Ltd. is registered with the FDA (registration 3017674095) in Rizhao Shandong, China. It lists 7 device types. The FDA files 13 510(k) clearances under its listings, the newest dated December 12, 2025. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3017674095
- Address
- No.2 North Zhaoyang Road, District of Donggang, Rizhao Shandong, China, 276800
- Owner or operator
- Rizhao HuGe Biomaterials Company, Ltd. (10078492)
- Roles
- Manufacturer
- First device listed
- October 23, 2020
- Registered through
- 2027
- Brand names listed
- Dual Cure Resin Cement, HF-Etchant Hydrofluoric Acid Etching Gel, Light Cure Dental Adhesive, Phosphoric Acid Etching Gel, Proseal Enamel Coating Resin, TempFIT Temporary Crown and Bridge Resin, TopCEM Ceramic Primer Ceramic Coupling Agent, TopCEM Dual Cure Resin Cement and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| External Cleaning Solution | PME | 2 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 12, 2025 | K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | EMA | Substantially Equivalent | Rizhao Huge Biomaterials Company, Ltd. | accessdata.fda.gov |
| June 23, 2025 | K251271 | TempFIT Temporary Crown and Bridge Resin | EBG | Substantially Equivalent | Rizhao Huge Biomaterials Company, Ltd. | accessdata.fda.gov |
| December 20, 2024 | K242572 | TopCEM-Try in Veneer Try-in Gel | EBF | Substantially Equivalent | Rizhao Huge Biomaterials Company, Ltd. | accessdata.fda.gov |
| December 20, 2024 | K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | KLE | Substantially Equivalent | Rizhao Huge Biomaterials Company, Ltd. | accessdata.fda.gov |
| November 8, 2024 | K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | KLE | Substantially Equivalent | Rizhao Huge Biomaterials Company, Ltd. | accessdata.fda.gov |
| June 28, 2024 | K241204 | TopCEM-Veneer Light Cure Veneer Cement | EMA | Substantially Equivalent | Rizhao Huge Biomaterials Company, Ltd. | accessdata.fda.gov |
| December 22, 2023 | K233082 | TopCEM Dual Cure Resin Cement | EBF | Substantially Equivalent | Rizhao Huge Biomaterials Company, Ltd. | accessdata.fda.gov |
| July 25, 2023 | K230455 | Enamel Coating Resin | EBC | Substantially Equivalent | Rizhao Huge Biomaterials Company, Ltd. | accessdata.fda.gov |
| October 12, 2022 | K221510 | TrusFIL-Flow Flowable Composite Restorative | EBF | Substantially Equivalent | Rizhao Huge Biomaterials Company, Ltd. | accessdata.fda.gov |
| September 12, 2022 | K221450 | Phosphoric Acid Etching Gel | KLE | Substantially Equivalent | Rizhao Huge Biomaterials Company, Ltd. | accessdata.fda.gov |
| October 6, 2021 | K202063 | TrusFIL Universal Composite Restorative | EBF | Substantially Equivalent | Rizhao Huge Biomaterials Company, Ltd. | accessdata.fda.gov |
| September 29, 2020 | K201790 | Dual Cure Resin Cement | EMA | Substantially Equivalent | Rizhao Huge Biomaterials Company, Ltd. | accessdata.fda.gov |
| September 25, 2020 | K201787 | Light Cure Dental Adhesive | KLE | Substantially Equivalent | Rizhao Huge Biomaterials Company, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Agent, Tooth Bonding, Resin
- All makers of Cement, Dental
- All makers of Material, Tooth Shade, Resin
- All makers of Sealant, Pit And Fissure, And Conditioner
- All makers of Crown And Bridge, Temporary, Resin
- All makers of External Cleaning Solution
Updated December 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.