BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    ZIRKONZAHN SRL

    Reg #: 3005904906 · FEI: 3005904906 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    18

    Registration Details

    Registration Name
    ZIRKONZAHN SRL
    Registration Number
    3005904906
    FEI Number
    3005904906
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA AN DER AHR 7
    City
    Gais Bolzano
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K061851

    Owner / Operator

    Firm Name
    ZIRKONZAHN SRL
    Operator Number
    9089299
    Address
    VIA AN DER AHR 7, --
    City
    Gais
    State
    Bolzano
    Postal Code
    39030
    Country
    IT
    Correspondent
    JULIAN - STEGER

    US Agent

    Business Name
    Zirkonzahn USA
    Contact Name
    Julian Steger
    Address
    154 Technology Pkwy
    City
    Norcross
    State
    GA
    ZIP
    30092
    Country
    US
    Email
    [email protected]
    Phone
    800 9898931

    Products

    Device Name Product Code
    Powder, Porcelain EIH
    Wax, Dental, Intraoral EGD
    System, Image Processing, Radiological LLZ
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Mouthguard, Prescription MQC
    Crown And Bridge, Temporary, Resin EBG
    Guide, Surgical, Instrument FZX
    Crown And Bridge, Long-Term Temporary, Resin POW
    System, X-Ray, Film Marking, Radiographic JAC
    Denture Preformed (Partially Prefabricated Denture) EKO
    Material, Impression Tray, Resin EBH
    Material, Tooth Shade, Resin EBF
    Denture, Plastic, Teeth ELM
    Accessories, Implant, Dental, Endosseous NDP
    Alloy, Metal, Base EJH
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Articulators EJP
    Additively Manufactured, Preformed, Resin Denture Tooth PZY

    Proprietary Names

    ICE Prettau Aquarell ICE Zirkon ICE Zirkon Stains Color Liquids SY1620 ZIRKONZAHN.Implant-Planner Practice SY1600 ZIRKONZAHN.Implant-Planner SY1670 ZIRKONZAHN.Implant-Planner Practice incl. Bone & Tooth Segmentation SY1660 ZIRKONZAHN.Implant-Planner incl. Bone & Tooth Segmentation ICE Transluzent Plus

    Establishment Types

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