BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ENVISIONTEC GMBH

    Reg #: 3012389497 · FEI: 3012389497 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    ENVISIONTEC GMBH
    Registration Number
    3012389497
    FEI Number
    3012389497
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Bruesseler Strasse 51
    City
    Gladbeck North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K211101

    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
    Crown And Bridge, Temporary, Resin EBG
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Applicator, Absorbent Tipped, Sterile KXG
    Mouthguard, Prescription MQC
    Accessories, Implant, Dental, Endosseous NDP
    Positioner, Tooth, Preformed KMY
    Additively Manufactured, Preformed, Resin Denture Tooth PZY
    Denture, Plastic, Teeth ELM
    Material, Tooth Shade, Resin EBF
    Material, Impression Tray, Resin EBH

    Proprietary Names

    Flexcera™ Smile Ultra+ E-Temp Flexcera™ Base E1-Guide Soft C-29C NP Swabs E-Guard blue E-Guard E-Guide SmileGuard Flexcera™ Smile E-Dent 1000 Flexcera™ Base Ultra+ E-Tray

    Establishment Types

    Manufacture Medical Device