BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SM Internal/External Implant System

    Reg #: 3007126709 · FEI: 3007126709 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    28
    Establishment Types
    1
    Classifications
    1

    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
    K070569

    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

    Proprietary Names

    SM Internal/External Implant System UF(II) Internal Cemented Abutment DIO Retainer UF(II) Internal Solid Abutment SM Internal Fixture IFI Angled Abutment FSN UCLA Plastic Abutment UF(II) Internal Healing Abutment UF(II) Internal Closing Screw IFI Healing Cap UF(II) Internal Excellent Solid Abutment SM Dental Implant System UF(II) Internal Ball Abutment UF(II) Internal Protect Cap UF(II) Internal Healing Cap UF(II) Internal Extension Cemented Abutment UF(II) Internal Gold Cylinder SM Fixture UF(II) Internal Angled Abutment IFI Healing Abutment IFI Cover Screw UF(II) Internal Plastic Cylinder UF(II) Internal Fixture UF(II) Internal Cover Screw DIO Ball Cap SM External Fixture UF(II) Internal Octa Abutment IFI Extension Cemented Abutment

    Establishment Types

    Manufacture Medical Device