BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    KULZER GMBH

    Reg #: 9610902 · FEI: 3002807166 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    37
    Establishment Types
    2
    Classifications
    12

    Registration Details

    Registration Name
    KULZER GMBH
    Registration Number
    9610902
    FEI Number
    3002807166
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    PHILIPP-REIS-STRASSE 8/13
    City
    WEHRHEIM Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K123278

    Owner / Operator

    Firm Name
    Kulzer, LLC
    Operator Number
    9056636
    Address
    4315 S. Lafayette Blvd.
    City
    South Bend
    State
    IN
    Postal Code
    46614
    Country
    US

    US Agent

    Business Name
    Kulzer, LLC
    Contact Name
    David Vincent
    Address
    4315 S Lafayette Blvd
    City
    South Bend
    State
    IN
    ZIP
    46614
    Country
    US
    Email
    [email protected]
    Phone
    574 2995421

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF
    Material, Impression ELW
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Activator, Ultraviolet, For Polymerization EBZ
    Agent, Tooth Bonding, Resin KLE
    Sealant, Pit And Fissure, And Conditioner EBC
    Varnish, Cavity LBH
    Tray, Impression, Preformed EHY
    Crown And Bridge, Temporary, Resin EBG
    Additively Manufactured, Preformed, Resin Denture Tooth PZY
    Coating, Filling Material, Resin EBD
    Cord, Retraction MVL

    Proprietary Names

    Signum Opaque F FLEXITIME MONOPHASE PRO SCAN Charisma Palaseal Palabond ibond Etch 35 Fluid IBond Universal and iBond Ceramic Primer Venus Diamond Flow iBond Etch 35 Gel Gluma Etch 35 Gel PALA cre-active Pala Digital Denture Tray Refill Pala Digital Impression Tray Universal Silicone Adhesive Pala Digital Denture Starter Kit Venus Diamond Venus Pearl Venus Bulk Flow One dima Print Teeth & Temp Charisma ABC Venus Pearl ONE Signum composite flow Signum cre-active Signum liquid Signum metal bond Signum universal bond Signum composite Signum matrix Venus Bulk Flow ONE Signum Connector Venus Flow Gluma Desensitizer iBond Total Etch Gluma Comfort Bond + Desensitizer iBond Self Etch Retraxil blue Venus Diamond ONE

    Establishment Types

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