BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    SEVEN MGuide

    Reg #: 3004203816 · FEI: 3004203816 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MIS Implants Technologies Ltd.
    Registration Number
    3004203816
    FEI Number
    3004203816
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BAR LEV INDUSTRIAL PARK P.O.BOX 7
    City
    BAR LEV INDUSTRIAL PARK Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K040807

    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
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    SEVEN MGuide MIS DENTAL IMPLANT SYSTEM Seven, M4, Lance Implants

    Establishment Types

    Manufacture Medical Device