BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SM II Fixture

    Reg #: 3011891801 · FEI: 3011891801 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    POINTIMPLANT Co., Ltd
    Registration Number
    3011891801
    FEI Number
    3011891801
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    B1 and 3F, 7, Hyoyeol-ro, Buk-gu
    City
    Busan
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K222738

    Owner / Operator

    Firm Name
    PointImplant Co Ltd
    Operator Number
    10083213
    Address
    B1 and 3F, 7, Hyoyeol-ro, Buk-gu
    City
    Busan
    State
    KR-26
    Postal Code
    46509
    Country
    KR
    Correspondent
    Joarak Chung

    US Agent

    Business Name
    Mtech Group LLC
    Contact Name
    Dave Kim
    Address
    7505 Fannin St. Suite 610
    City
    Houston
    State
    TX
    ZIP
    77054
    Country
    US
    Email
    [email protected]
    Phone
    713 4672607

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    SM II Fixture Healing Abutment Cemented Abutment Solid Cap Temporary Abutment Angled Abutment Solid Abutment Abutment Screw Fixture Mount Cover Screw Fixture Mount Screw

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device