Rizhao Huge Biomaterials Company, Ltd.
FDA 510(k) & PMA Approved Devices — 13 products
Total Devices13
Categories5
Latest Approval2025-12-12
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | EMA | 2025-12-12 | View |
| 510(k) | K251271 | TempFIT Temporary Crown and Bridge Resin | EBG | 2025-06-23 | View |
| 510(k) | K242572 | TopCEM-Try in Veneer Try-in Gel | EBF | 2024-12-20 | View |
| 510(k) | K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | KLE | 2024-12-20 | View |
| 510(k) | K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | KLE | 2024-11-08 | View |
| 510(k) | K241204 | TopCEM-Veneer Light Cure Veneer Cement | EMA | 2024-06-28 | View |
| 510(k) | K233082 | TopCEM Dual Cure Resin Cement | EBF | 2023-12-22 | View |
| 510(k) | K230455 | Enamel Coating Resin | EBC | 2023-07-25 | View |
| 510(k) | K221510 | TrusFIL-Flow Flowable Composite Restorative | EBF | 2022-10-12 | View |
| 510(k) | K221450 | Phosphoric Acid Etching Gel | KLE | 2022-09-12 | View |
| 510(k) | K202063 | TrusFIL Universal Composite Restorative | EBF | 2021-10-06 | View |
| 510(k) | K201790 | Dual Cure Resin Cement | EMA | 2020-09-29 | View |
| 510(k) | K201787 | Light Cure Dental Adhesive | KLE | 2020-09-25 | View |
No matching devices.