BEUDAMED
    FDA Registration Active 🇨🇳 China

    RIZHAO HUGE BIOMATERIALS COMPANY, LTD.

    Reg #: 3017674095 · FEI: 3017674095 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    7

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    Registration Details

    Registration Name
    RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
    Registration Number
    3017674095
    FEI Number
    3017674095
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.2 North Zhaoyang Road, District of Donggang
    City
    Rizhao Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K233082

    Owner / Operator

    Firm Name
    Rizhao HuGe Biomaterials Company, Ltd.
    Operator Number
    10078492
    Address
    No.2 North Zhaoyang Road, District of Donggang
    City
    Rizhao
    State
    Shandong
    Postal Code
    276800
    Country
    CN
    Correspondent
    Maggie Zheng

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF
    Cement, Dental EMA
    Agent, Tooth Bonding, Resin KLE
    Sealant, Pit And Fissure, And Conditioner EBC
    Crown And Bridge, Temporary, Resin EBG
    Powder, Porcelain EIH
    External Cleaning Solution PME

    Proprietary Names

    TopCEM Dual Cure Resin Cement UltraCore Dual Cure Resin Cement Dual Cure Resin Cement TopCEM-Try in Veneer Try-in Gel Light Cure Dental Adhesive Phosphoric Acid Etching Gel TopCEM Vigor SA Self-Adhesive Resin Cement TrusFIL-Flow Flowable Composite Restorative Proseal Enamel Coating Resin TopCEM-Veneer Light Cure Veneer Cement TempFIT Temporary Crown and Bridge Resin HF-Etchant Hydrofluoric Acid Etching Gel TrusFIL Universal Composite Restorative TopCEM Ceramic Primer Ceramic Coupling Agent

    Establishment Types

    Manufacture Medical Device