BEUDAMED
    FDA Registration Active 🇨🇳 China

    HygePLUS Alginate Impression Material

    Reg #: 3011187729 · FEI: 3011187729 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    HYGEDENT INC.
    Registration Number
    3011187729
    FEI Number
    3011187729
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gate E, Building 1, No.97 Changping Road, Shahe Town, Changping District
    City
    Beijing
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K170812

    Owner / Operator

    Firm Name
    HYGEDENT INC.
    Operator Number
    10047045
    Address
    Gate E, Building 1, No.97 Changping Road,, Shahe Town, Changping District ,
    City
    Beijing
    State
    CN-BJ
    Postal Code
    102206
    Country
    CN
    Correspondent
    Peng Wang

    US Agent

    Business Name
    Hygedent Dental Inc
    Contact Name
    Zoe Sun
    Address
    11622 El Camino Real, Suite 100
    City
    San Diego
    State
    CA
    ZIP
    92130
    Country
    US
    Email
    [email protected]
    Phone
    858 2614763

    Products

    Device Name Product Code
    Material, Impression ELW

    Proprietary Names

    HygePLUS Alginate Impression Material

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device