BEUDAMED
    FDA Registration Active 🇨🇳 China

    TopCEM Ceramic Primer Ceramic Coupling Agent

    Reg #: 3017674095 · FEI: 3017674095 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
    Registration Number
    3017674095
    FEI Number
    3017674095
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.2 North Zhaoyang Road, District of Donggang
    City
    Rizhao Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K242749

    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

    US Agent

    Business Name
    HUGE DENTAL USA LLC
    Contact Name
    Xin Song
    Address
    4010 Valley Blvd STE 104
    City
    Walnut
    State
    CA
    ZIP
    91789
    Country
    US
    Email
    [email protected]
    Phone
    626 2835808

    Products

    Device Name Product Code
    Cement, Dental EMA
    Agent, Tooth Bonding, Resin KLE

    Proprietary Names

    TopCEM Ceramic Primer Ceramic Coupling Agent

    Establishment Types

    Manufacture Medical Device