BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    KULZER GMBH

    Reg #: 3005665377 · FEI: 3005665377 · Expires 2026
    View on FDA
    Products
    25
    Proprietary Names
    99
    Establishment Types
    4
    Classifications
    25

    Registration Details

    Registration Name
    KULZER GMBH
    Registration Number
    3005665377
    FEI Number
    3005665377
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Leipziger StraBe 2
    City
    HANAU Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K042199

    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
    Activator, Ultraviolet, For Polymerization EBZ
    Material, Impression ELW
    Denture, Plastic, Teeth ELM
    Varnish, Cavity LBH
    Agent, Tooth Bonding, Resin KLE
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Maintainer, Space Preformed, Orthodontic DYT
    Clamp, Rubber Dam EEF
    Crown And Bridge, Temporary, Resin EBG
    Additively Manufactured, Preformed, Resin Denture Tooth PZY
    Disk, Abrasive EHJ
    Material, Tooth Shade, Resin EBF
    Instruments, Dental Hand DZN
    Amalgamator, Dental, Ac-Powered EFD
    Sealant, Pit And Fissure, And Conditioner EBC
    Material, Impression Tray, Resin EBH
    Coating, Filling Material, Resin EBD
    Frame, Rubber Dam EJE
    Forceps, Rubber Dam Clamp EJG
    Handle, Instrument, Dental EJB
    Dental Barriers And Sleeves PEM
    Cord, Retraction MVL
    Syringe, Restorative And Impression Material EID
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Tray, Impression, Preformed EHY

    Proprietary Names

    Translux Wave Translux 2 Wave TRANSLUX POWER BLUE Flexitime Light Flow Flexitime Medium Flow Artic Digital Artic Flexitime Monophase Flexitime Easy Putty Flexitime Heavy Tray Flexitime Correct Flow Flexitime Unlimited MONDIAL Mondial I iBond Total Etch Gluma Comfort Bond + Desensitizer Paladon 65 Venus Temp 2 Flexitime Bite Dima Print Splint Clear IVORY RUBBER DAM CLAMP Ivory Rubber Dam Complete Kit Ivory Rubber Dam Starter Kit IVORY RUBBER DAM INTRO KIT Starlight Pro dima Print Teeth & Temp Venus Supra Signum Opaque F FLEXITIME XTREME 2 Venus Flow Dispensing Gun 10:1 Dispensing Gun 2 (1:12:1) Dispensing Gun 4:1 Charisma ibond Etch 35 Fluid Delara Palabond Dynamix Speed 2 Cuttersil Light Cuttersil Putty Plus Signum Connector CUTTERSIL MUCOSA Venus Diamond Flow Dima Print Impression Blue Signum composite flow Signum cre-active Signum liquid Signum metal bond Signum universal bond Signum composite Signum matrix IBond Universal and iBond Ceramic Primer Ivory Ivory Rubber Dam Frame dima Print Denture Base 2 iBond Etch 35 Gel Gluma Etch 35 Gel IVORY RUBBER DAM FORCEPS Kulzer PLT Applicator Venus Diamond Venus Diamond ONE Palaseal Protective Sleeves for Syringes (Minitube) Retraxil blue Flexitime Dynamix Heavy Tray Flexitime Dynamix Putty Flexitime Dynamix Monophase Flexitime Magnum 360 dima Denture Base dima Print Try-In Flexitime dynamix mixing tips Mixing Tips: Green Flow Canules IOT White 96 IOT Yellow 96 BITE REG INTRAORAL HIP CD 96 Venus Pearl Venus Pearl ONE Venus Bulk Flow ONE Cuttersil Hardener Memoreg 2 Xantasil FLEXITIME MONOPHASE PRO SCAN Cara Scan 4i Cara Scan 4 BUNDLE Cara Scan 4 Cara i500 Venus Bulk Flow One Gluma Desensitizer dima Print Teeth PALA cre-active Palpress Vario MEMOSIL Pala Digital Denture Tray Refill Pala Digital Impression Tray Universal Silicone Adhesive Pala Digital Denture Starter Kit Charisma ABC dima Print Guide & Tray

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device