BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SmileGuard

    Reg #: 3012389497 · FEI: 3012389497 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ENVISIONTEC GMBH
    Registration Number
    3012389497
    FEI Number
    3012389497
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bruesseler Strasse 51
    City
    Gladbeck North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K220894

    Owner / Operator

    Firm Name
    EnvisionTEC GmbH
    Operator Number
    10053558
    Address
    Bruesseler Strasse 51
    City
    Gladbeck
    State
    North Rhine-Westphalia
    Postal Code
    D-45968
    Country
    DE
    Correspondent
    Mindy McCann

    US Agent

    Business Name
    Qserve Group US Inc.
    Contact Name
    Mindy McCann
    Address
    350 S Main Street, Suite 309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    Mouthguard, Prescription MQC
    Positioner, Tooth, Preformed KMY

    Proprietary Names

    SmileGuard

    Establishment Types

    Manufacture Medical Device