BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    DIO Dental Implant System

    Reg #: 3007126709 · FEI: 3007126709 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    46
    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
    K070570

    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

    DIO Dental Implant System FTN Healing Cap UF(II) Abutment Screw SM Solid Mill Abutment FSN Fixture FTN Cemented Abutment SM Solid Abutment SM Cemented Abutment IFI Angled Abutment FTN Abutment Screw IFI Fixture FTN Healing Abutment SM Angled Abutment PSI Fixture FTN UCLA Plastic Abutment SM Abutment Screw SM Mill Abutment SM Impression Cap FTN Angled Abutment SM UCLA Gold Abutment FTN Headless Screw FTN Ball Abutment FTN Temporary Abutment SM Transfer Impression Coping SM Temporary Abutment SM Fixture FTN External Fixture FTN Cylinder Screw SM Solid Impression Cap SM Ball Abutment FTN Conical Plastic Abutment FTN Straight Fixture FTN Gold Cylinder for Conical Abutment UF(II) Internal Cemented Abutment IFI Extension Cemented Abutment FTN Fixture SM Healing Abutment SM Protect Cap FTN Plastic Cylinder for Conical Abutment FTN Conical Abutment Screw FTN Temporary Cylinder FTN UCLA Gold Abutment Healing Abutment UF(II) Transfer Impression Coping FTN Cover Screw FTN Conical Abutment

    Establishment Types

    Manufacture Medical Device