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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
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.
K213994
12/21/2021
Flexible Block
Shandong Huge Dental Material Corporation
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