Rizhao Huge Biomaterials Company, Ltd.
Manufacturer and brand owner in Rizhao, Shandong, China. 7 device types, 13 products catalogued, 13 clearances.
Rizhao Huge Biomaterials Company, Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Cement, Dental, Powder, Porcelain and 5 other device types. 13 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
7device types registered with the FDA
13products catalogued under its own name
13510(k) clearances
Registration
| Registered name | RIZHAO HUGE BIOMATERIALS COMPANY, LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017674095 |
| FEI number | 3017674095 |
| DUNS | 544452689 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 日照沪鸽生物材料有限公司 |
|---|---|
| Unified social credit code | 91371100MA3C9GA34C |
| Source | NMPA UDI database |
Location
| City | Rizhao |
|---|---|
| Province | Shandong |
| Address | No.2 North Zhaoyang Road, District of Donggang |
| Postal code | 276800 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | Class 2 | HF-Etchant Hydrofluoric Acid Etching Gel, TopCEM Ceramic Primer Ceramic Coupling Agent, Phosphoric Acid Etching Gel, Light Cure Dental Adhesive | 2020 | 6 |
| Cement, Dental | Class 2 | TopCEM-Veneer Light Cure Veneer Cement, TopCEM Dual Cure Resin Cement, UltraCore Dual Cure Resin Cement, Dual Cure Resin Cement, TopCEM Ceramic Primer Ceramic Coupling Agent, TopCEM Vigor SA Self-Adhesive Resin Cement | 2020 | 3 |
| Crown And Bridge, Temporary, Resin | Class 2 | TempFIT Temporary Crown and Bridge Resin | 2025 | 13 |
| External Cleaning Solution | Class 2 | HF-Etchant Hydrofluoric Acid Etching Gel | 2024 | 3 |
| Material, Tooth Shade, Resin | Class 2 | TopCEM-Veneer Light Cure Veneer Cement, TopCEM Dual Cure Resin Cement, UltraCore Dual Cure Resin Cement, TopCEM-Try in Veneer Try-in Gel, Dual Cure Resin Cement, TrusFIL-Flow Flowable Composite Restorative and 1 more | 2020 | 10 |
| Powder, Porcelain | Class 2 | HF-Etchant Hydrofluoric Acid Etching Gel | 2024 | 33 |
| Sealant, Pit And Fissure, And Conditioner | Class 2 | Proseal Enamel Coating Resin | 2023 | 1 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| TrusFIL Universal Composite Restorative | EBF | 11 |
| Dual Cure Resin Cement | EMA | 7 |
| TopCEM Vigor SA Self-Adhesive Resin Cement | EMA | 7 |
| TopCEM Dual Cure Resin Cement | EBF | 7 |
| Enamel Coating Resin | EBC | 6 |
| Veneer Try-in Gel | EBF | 5 |
| Light Cure Veneer Cement | EMA | 5 |
| Phosphoric Acid Etching Gel | KLE | 3 |
| Temporary Crown and Bridge Resin | EBG | 2 |
| Ceramic Coupling Agent | KLE | 2 |
| TrusFIL-Flow Flowable Composite Restorative | EBF | 2 |
| Hydrofluoric Acid Etching Gel | KLE | 2 |
| Light Cure Dental Adhesive | KLE | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252785 | 2025-12-12 | EMA | Traditional | This company |
| K251271 | 2025-06-23 | EBG | Traditional | This company |
| K242572 | 2024-12-20 | EBF | Traditional | This company |
| K242530 | 2024-12-20 | KLE | Traditional | This company |
| K242749 | 2024-11-08 | KLE | Traditional | This company |
| K241204 | 2024-06-28 | EMA | Traditional | This company |
| K233082 | 2023-12-22 | EBF | Traditional | This company |
| K230455 | 2023-07-25 | EBC | Traditional | This company |
| K221510 | 2022-10-12 | EBF | Traditional | This company |
| K221450 | 2022-09-12 | KLE | Traditional | This company |
| K202063 | 2021-10-06 | EBF | Traditional | This company |
| K201790 | 2020-09-29 | EMA | Traditional | This company |
| K201787 | 2020-09-25 | KLE | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Dental materials, Composite cements, Biomaterials |
|---|
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Rizhao Sanqi Medical & Health Articles Co., Ltd. | 18 |
| Shandong Huge Dental Material Corporation | 17 |
| Shandong INT Medical Instruments Co., Ltd. | 4 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.