BEUDAMED
    FDA Registration Active 🇦🇷 Argentina

    ODONTIT, HEX IMPLANT, INTERNAL HEX, SQUARE, MONOBLOCK, BALL, EFEDEA, SWISS IMPLANT, SMARTGRIP, OSSEOMATE, ORTHOSOURCE

    Reg #: 9680963 · FEI: 3000278038 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ODONTIT SA
    Registration Number
    9680963
    FEI Number
    3000278038
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Necochea 854
    City
    BUENOS AIRES Buenos Aires, Ciudad Autonoma de
    Country
    AR

    Regulatory Submissions

    510(k) Number
    K961631

    Owner / Operator

    Firm Name
    ODONTIT SA
    Operator Number
    9012625
    Address
    Necochea 854, --
    City
    BUENOS AIRES
    State
    AR-NOTA
    Postal Code
    1158
    Country
    AR
    Correspondent
    MARIO - GERSBERG

    US Agent

    Business Name
    ORTHOSURCE, INC.
    Contact Name
    LLOYD R. TAYLOR
    Address
    13343 Sherman Way
    City
    N Hollywood
    State
    CA
    ZIP
    91605
    Country
    US
    Email
    [email protected]
    Phone
    818 9829445

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    ODONTIT, HEX IMPLANT, INTERNAL HEX, SQUARE, MONOBLOCK, BALL, EFEDEA, SWISS IMPLANT, SMARTGRIP, OSSEOMATE, ORTHOSOURCE Kalos Biomedical

    Establishment Types

    Manufacture Medical Device Foreign Private Label Distributor Manufacture Medical Device for Another Party (Contract Manufacturer)