BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    SureSmile Aligner Transfer Tray

    Reg #: 3017619720 · FEI: 3017619720 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Orthodental S.A. de C.V.
    Registration Number
    3017619720
    FEI Number
    3017619720
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Calle el Dorado #2 interior C & D, Parque Industrial El Dorado
    City
    Mexicali Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K171860

    Owner / Operator

    Firm Name
    DENTSPLY SIRONA INC
    Operator Number
    2511302
    Address
    221 WEST PHILADELPHIA ST., SUITE 60W
    City
    York
    State
    PA
    Postal Code
    17401
    Country
    US

    US Agent

    Business Name
    DENTSPLY SIRONA INC
    Contact Name
    Dan Eagar
    Address
    13320 Ballantyne Corp Pl
    City
    Charlotte
    State
    NC
    ZIP
    28277
    Country
    US
    Email
    [email protected]
    Phone
    704 4926977

    Products

    Device Name Product Code
    Aligner, Sequential NXC

    Proprietary Names

    SureSmile Aligner Transfer Tray SureSmile Aligner

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)