BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    DTX Studio Diagnose

    Reg #: 3005383085 · FEI: 3005383085 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PALODEX GROUP OY
    Registration Number
    3005383085
    FEI Number
    3005383085
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NAHKELANTIE 160
    City
    Tuusula Uusimaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K172224

    Owner / Operator

    Firm Name
    PaloDEx Group Oy
    Operator Number
    9079085
    Address
    Nahkelantie 160, --
    City
    TUUSULA
    State
    Uusimaa
    Postal Code
    04300
    Country
    FI

    US Agent

    Business Name
    DENTAL IMAGING TECHNOLOGIES CORPORATION
    Contact Name
    Erika Martin
    Address
    450 Commerce Drive
    City
    Quakertown
    State
    PA
    ZIP
    18951
    Country
    US
    Email
    [email protected]
    Phone
    980 3094441

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    DTX Studio Diagnose

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198