FDA 510(k) Applications Submitted by Maggie Zheng
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K230455 |
02/21/2023 |
Enamel Coating Resin |
Rizhao HuGe Biomaterials Company, Ltd. |
| K220680 |
03/08/2022 |
Denture Base Polymers |
Shandong Huge Dental Material Corporation |
| K251271 |
04/24/2025 |
TempFIT Temporary Crown and Bridge Resin |
Rizhao HuGe Biomaterials Company, Ltd. |
| K241204 |
04/30/2024 |
TopCEM-Veneer Light Cure Veneer Cement |
Rizhao HuGe Biomaterials Company, Ltd. |
| K221450 |
05/18/2022 |
Phosphoric Acid Etching Gel |
Rizhao HuGe Biomaterials Company, Ltd. |
| K221510 |
05/24/2022 |
TrusFIL-Flow Flowable Composite Restorative |
Rizhao HuGe Biomaterials Company, Ltd. |
| K201683 |
06/22/2020 |
PMMA Block |
Huge Dental Material Co., Ltd. |
| K201684 |
06/22/2020 |
A-Silicone for Bite Registration |
Shandong Huge Dental Material Corporation |
| K201787 |
06/30/2020 |
Light Cure Dental Adhesive |
Rizhao HuGe Biomaterials Company, Ltd. |
| K201790 |
06/30/2020 |
Dual Cure Resin Cement |
Rizhao HuGe Biomaterials Company, Ltd. |
| K181747 |
07/02/2018 |
Orthodontic Appliance |
Shandong Huge Dental Material Corporation |
| K202063 |
07/27/2020 |
TrusFIL Universal Composite Restorative |
Rizhao HuGe Biomaterials Company, Ltd. |
| K242530 |
08/26/2024 |
HF-Etchant Hydrofluoric Acid Etching Gel |
Rizhao HuGe Biomaterials Company, Ltd. |
| K242572 |
08/29/2024 |
TopCEM-Try in Veneer Try-in Gel |
Rizhao HuGe Biomaterials Company, Ltd. |
| K242749 |
09/12/2024 |
TopCEM Ceramic Primer Ceramic Coupling Agent |
Rizhao HuGe Biomaterials Company, Ltd. |
| K233082 |
09/26/2023 |
TopCEM Dual Cure Resin Cement |
Rizhao HuGe Biomaterials Company, Ltd. |
| K213994 |
12/21/2021 |
Flexible Block |
Shandong Huge Dental Material Corporation |
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