BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    AR_N SLA Type Implant System

    Reg #: 3009611645 · FEI: 3009611645 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOTEM CO., LTD.
    Registration Number
    3009611645
    FEI Number
    3009611645
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    # 422, Sasang-ro, Sasang-gu
    City
    Busan
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K190641

    Owner / Operator

    Firm Name
    Biotem Co., Ltd.
    Operator Number
    10057313
    Address
    # 422, Sasang-ro, Sasang-gu
    City
    Busan
    State
    KR-26
    Postal Code
    46925
    Country
    KR

    US Agent

    Business Name
    GS GLOBAL USA, INC
    Contact Name
    Seong han Chung
    Address
    17785 Center Court Dr., Suite 260
    City
    Cerritos
    State
    CA
    ZIP
    90703
    Country
    US
    Email
    [email protected]
    Phone
    562 7773106

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    AR_N SLA Type Implant System Bone Level Fixture

    Establishment Types

    Manufacture Medical Device