BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    HySil Super Fast Impression Material

    Reg #: 3015332784 · FEI: 3015332784 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OSSTEM IMPLANT CO., LTD.
    Registration Number
    3015332784
    FEI Number
    3015332784
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    A-DONG, 51, MAYU-RO 238BEON-GIL
    City
    SIHEUNG Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K192941

    Owner / Operator

    Firm Name
    OSSTEM IMPLANT CO LTD
    Operator Number
    9062743
    Address
    66-16, Bansong-ro 513beon-gil,
    City
    Haeundae-gu
    State
    Busan
    Postal Code
    48002
    Country
    KR
    Correspondent
    Hae Sung - Kim

    US Agent

    Business Name
    HIOSSEN, Inc.
    Contact Name
    Mateusz Leszczak
    Address
    85 Ben Fairless Drive
    City
    Fairless Hills
    State
    PA
    ZIP
    19030
    Country
    US
    Email
    [email protected]
    Phone
    201 2660657

    Products

    Device Name Product Code
    Material, Impression ELW

    Proprietary Names

    HySil Super Fast Impression Material

    Establishment Types

    Manufacture Medical Device