BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DREVE DENTAMID GMBH

    Reg #: 1000486347 · FEI: 1000486347 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    27
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    DREVE DENTAMID GMBH
    Registration Number
    1000486347
    FEI Number
    1000486347
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    MAX-PLANCK-STR. 31
    City
    UNNA North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K241226

    Owner / Operator

    Firm Name
    DREVE DENTAMID GMBH
    Operator Number
    9042374
    Address
    MAX-PLANCK-STRASSE 31
    City
    UNNA
    State
    North Rhine-Westphalia
    Postal Code
    59423
    Country
    DE

    US Agent

    Business Name
    DREVE AMERICA CORP.
    Contact Name
    Robert Nickoloff
    Address
    6477 City West Pkwy
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US
    Email
    [email protected]
    Phone
    651 3249494

    Products

    Device Name Product Code
    Material, Impression ELW
    Syringe, Restorative And Impression Material EID
    Accessories, Implant, Dental, Endosseous NDP
    Crown And Bridge, Temporary, Resin EBG
    Aligner, Sequential NXC
    Positioner, Tooth, Preformed KMY
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Coating, Filling Material, Resin EBD
    Plate, Base, Shellac EEA
    Cement, Dental EMA
    Material, Impression Tray, Resin EBH

    Proprietary Names

    Tips Application tips Mixing tips FotoDent guide Fixtemp C&B 4:1 Primeprint Direct Aligner Drufosoft pro Drufosoft BioBleach hart/soft Odontosil 50/60 Odontosil 2K Lack Drufolen H Kombiplast Biolon FotoDent denture NanoVarnish Plaquit FotoDent TryIn StoneBite, StoneBite scan Dynax heavy body Dynax clear Dynax light Dynax mono Dynax putty FotoDent IBT FotoDent tray2 Drufoplast

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device