Dual Cure Resin Cement
Rizhao Huge's Dual Cure Resin Cement fixes dental restorations such as crowns, bridges, inlays, veneers and posts. It hardens through a chemical curing reaction and can also be cured using…
Rizhao Huge’s Dual Cure Resin Cement fixes dental restorations such as crowns, bridges, inlays, veneers and posts. It hardens through a chemical curing reaction and can also be cured using light.
The base and catalyst pastes contain methacrylate resins, inorganic fillers, pigments and curing components. Equal volumes of the two pastes are mixed to form the luting cement.
Delivery and Shades
Hand-mix versions use two separate syringes, while Automix versions use a double-barrel syringe. Seven shades include translucent, tooth-colored and opaque options. The cement is radiopaque for identification on X-rays and is intended for restorations made from metal, metal-ceramic, ceramic, porcelain, composite or combinations of these materials.
Who Else Makes It
Concentrated in Shandong (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
Record
| Listed by | Rizhao Huge Biomaterials Company, Ltd., China |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Manufacturer |
| 510(k) | K201790 |
| Record published | 2023-11-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-11-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Automix | In distribution | |
| Automix | In distribution | |
| Automix | In distribution | |
| Automix | In distribution | |
| Automix | In distribution | |
| Automix | In distribution | |
| Automix | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GC Fuji II LC® | GC America Inc. | 78 |
| Equia® | GC America Inc. | 73 |
| Riva SC | SDI Ltd. | 72 |
| Denture Base | American Tooth Industries | 61 |
| Riva LC | SDI Ltd. | 59 |
| GC Fuji IX GP® | GC America Inc. | 58 |
| GlasIonomer FX-LC | Shofu Dental Corp. | 45 |
| Henry Schein | Henry Schein, Inc. | 35 |
| Esthet-X®flow Liquid Micro Hybrid | Dentsply LLC | 24 |
| Photac™ Fil Quick Aplicap™ | 3M Deutschland GmbH | 24 |
| Ketac™ Fil Plus Aplicap™ | 3M Deutschland GmbH | 23 |
| Ultra-Bond® | DEN-MAT Holdings, LLC | 23 |
Showing 12 of 780. All products under Cement, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252785 | 2025-12-12 |
| K241204 | 2024-06-28 |
| K201790 | 2020-09-29 |
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.