Manufacturer registered with FDA
Rizhao HuGe Biomaterials Company, Ltd.
Rizhao, China. Lists 7 dental device types with FDA across 1 registered establishment, and holds 13 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 21
- 510(k) clearances
- 132020–2025
- Markets registered in
- 49 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Rizhao HuGe Biomaterials Company, Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Rizhao HuGe Biomaterials Company, Ltd. | 13 clearances | 2020–2025 | Below |
| Taiwan | TFDA | Manufacturer | Rizhao HuGe Biomaterials Company, Ltd. | 5 | 2023–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | RIZHAO HUGE BIOMATERIALS COMPANY, LTD. | 3 | 2022–2023 | Pure Global AI |
| Israel | AMAR | Manufacturer | Rizhao HuGe Biomaterials Company, Ltd. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Rizhao HuGe Biomaterials Company, Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Dual Cure Resin CementTopCEM Dual Cure Resin CementTopCEM-Try in Veneer Try-in GelTopCEM-Veneer Light Cure Veneer CementTrusFIL Universal Composite RestorativeTrusFIL-Flow Flowable Composite RestorativeUltraCore Dual Cure Resin Cement | 2020 |
| Dental CementEMA · Class 2 | Dental cements | Maker | Dual Cure Resin CementTopCEM Ceramic Primer Ceramic Coupling AgentTopCEM Dual Cure Resin CementTopCEM Vigor SA Self-Adhesive Resin CementTopCEM-Veneer Light Cure Veneer CementUltraCore Dual Cure Resin Cement | 2020 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | HF-Etchant Hydrofluoric Acid Etching GelLight Cure Dental AdhesivePhosphoric Acid Etching GelTopCEM Ceramic Primer Ceramic Coupling Agent | 2020 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | Proseal Enamel Coating Resin | 2023 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | TempFIT Temporary Crown and Bridge Resin | 2025 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | HF-Etchant Hydrofluoric Acid Etching Gel | 2024 |
| External Cleaning SolutionPME · Class 2 | — | Maker | HF-Etchant Hydrofluoric Acid Etching Gel | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Rizhao HuGe Biomaterials Company, Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 12 Dec 2025 | K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | EMA Dental Cement |
| 23 Jun 2025 | K251271 | TempFIT Temporary Crown and Bridge Resin | EBG Resin Temporary Crown and Bridge |
| 20 Dec 2024 | K242572 | TopCEM-Try in Veneer Try-in Gel | EBF Resin Tooth Shade Material |
| 20 Dec 2024 | K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | KLE Resin Tooth Bonding Agent |
| 8 Nov 2024 | K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | KLE Resin Tooth Bonding Agent |
| 28 Jun 2024 | K241204 | TopCEM-Veneer Light Cure Veneer Cement | EMA Dental Cement |
| 22 Dec 2023 | K233082 | TopCEM Dual Cure Resin Cement | EBF Resin Tooth Shade Material |
| 25 Jul 2023 | K230455 | Enamel Coating Resin | EBC Pit and Fissure Sealant and Conditioner |
| 12 Oct 2022 | K221510 | TrusFIL-Flow Flowable Composite Restorative | EBF Resin Tooth Shade Material |
| 12 Sep 2022 | K221450 | Phosphoric Acid Etching Gel | KLE Resin Tooth Bonding Agent |
| 6 Oct 2021 | K202063 | TrusFIL Universal Composite Restorative | EBF Resin Tooth Shade Material |
| 29 Sep 2020 | K201790 | Dual Cure Resin Cement | EMA Dental Cement |
| 25 Sep 2020 | K201787 | Light Cure Dental Adhesive | KLE Resin Tooth Bonding Agent |
Some of these clearances are listed with FDA today by another company: Shandong Huge Dental Material Corporation (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| RIZHAO HUGE BIOMATERIALS COMPANY, LTD.FDA reg. 3017674095 | Rizhao Shandong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10078492). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.