BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SM-Extra Wide(RBM) Implant System

    Reg #: 3007126709 · FEI: 3007126709 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DIO Corporation
    Registration Number
    3007126709
    FEI Number
    3007126709
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    66, Centumseo-ro
    City
    Haeundae-gu Busan
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K073070

    Owner / Operator

    Firm Name
    DIO Corporation
    Operator Number
    9089142
    Address
    66, Centumseo-ro, --
    City
    Haeundae-gu
    State
    Busan
    Postal Code
    48058
    Country
    KR

    US Agent

    Business Name
    DIO USA CORPORATION
    Contact Name
    Peter Kang
    Address
    1932 E Deere Ave Ste 100
    City
    Santa Ana
    State
    CA
    ZIP
    92705
    Country
    US
    Email
    [email protected]
    Phone
    714 8804141

    Products

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

    Proprietary Names

    SM-Extra Wide(RBM) Implant System SM Solid Abutment (II) SM Healing Abutment SM Cover Screw SM Cemented Abutment (II) SM Extra Wide Fixture SM Cemented Abutment

    Establishment Types

    Manufacture Medical Device