BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    I-Sil

    Reg #: 3006113314 · FEI: 3006113314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SPIDENT CO., LTD.
    Registration Number
    3006113314
    FEI Number
    3006113314
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    312, 151B-6L NAMDONGGONGDAN
    City
    INCHEON Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K161774

    Owner / Operator

    Firm Name
    SPIDENT CO., LTD.
    Operator Number
    9089446
    Address
    312, 151B-6L NAMDONGGONGDAN, --
    City
    INCHEON
    State
    KR-NOTA
    Postal Code
    405-821
    Country
    KR

    US Agent

    Business Name
    Withus Group Inc
    Contact Name
    April Lee
    Address
    106 Superior
    City
    Irvine
    State
    CA
    ZIP
    92620
    Country
    US
    Email
    [email protected]
    Phone
    909 2749971

    Products

    Device Name Product Code
    Material, Impression ELW

    Proprietary Names

    I-Sil Vaccu-SiL Delikit Premium Heavy Body Fast Delikit Premium Heavy Body Vinyl Poly Siloxane Fast Putty Premium Delikit Premium Light Body Delikit Premium Light Body Fast

    Establishment Types

    Manufacture Medical Device