BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    AMII Implant System

    Reg #: 3008309654 · FEI: 3008309654 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    INNOBIOSURG CO., LTD.
    Registration Number
    3008309654
    FEI Number
    3008309654
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    44-19, Techno Street 10, YUSUNG-GU,
    City
    Daejeon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K152520

    Owner / Operator

    Firm Name
    InnoBioSurg Co.,Ltd
    Operator Number
    10032324
    Address
    44-19, Techno Street 10,, Yuseong-gu,
    City
    Daejeon
    State
    KR-30
    Postal Code
    305500
    Country
    KR
    Correspondent
    Je Won Wang

    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
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    AMII Implant System

    Establishment Types

    Manufacture Medical Device