BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    OSSTEM IMPLANT CO., LTD.

    Reg #: 3015332784 · FEI: 3015332784 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    OSSTEM IMPLANT CO., LTD.
    Registration Number
    3015332784
    FEI Number
    3015332784
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    A-DONG, 51, MAYU-RO 238BEON-GIL
    City
    SIHEUNG Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K210041

    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

    US Agent

    Business Name
    HIOSSEN, Inc.
    Contact Name
    Martin Shin
    Address
    85 Ben Fairless Drive
    City
    Fairless Hills
    State
    PA
    ZIP
    19030
    Country
    US
    Email
    [email protected]
    Phone
    267 7106714

    Products

    Device Name Product Code
    Material, Impression ELW
    Syringe, Restorative And Impression Material EID
    Powder, Porcelain EIH

    Proprietary Names

    HySil Plus Impression Materials HySil Super Fast Impression Material Hysil Impression Material SUFLEX 50ML Impression Gun OSSTEM Mixing Tip HySil Impression Materials (Heavy, Mono, and Bite) Estar-ZE Estar-Z T Estar-Z Multi Estar-Z HT Estar-Z ST

    Establishment Types

    Manufacture Medical Device