BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    TrueDent Cyan

    Reg #: 3017374693 · FEI: 3017374693 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    STRATASYS LTD - Headquarter
    Registration Number
    3017374693
    FEI Number
    3017374693
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Holtzman street
    City
    Rehovot Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K220771

    Owner / Operator

    Firm Name
    Stratasys Ltd
    Operator Number
    10086646
    Address
    1 Holtzman street
    City
    Rehovot
    State
    Central
    Postal Code
    7612401
    Country
    IL
    Correspondent
    Dafna Fitoussi

    US Agent

    Business Name
    Stratasys Inc.
    Contact Name
    Mirza Kubiak
    Address
    5995 Opus Pkwy
    City
    Minnetonka
    State
    MN
    ZIP
    55343
    Country
    US
    Email
    [email protected]
    Phone
    661 2954448

    Products

    Device Name Product Code
    Crown And Bridge, Temporary, Resin EBG
    Material, Tooth Shade, Resin EBF
    Additively Manufactured, Preformed, Resin Denture Tooth PZY
    Resin, Denture, Relining, Repairing, Rebasing EBI

    Proprietary Names

    TrueDent Cyan TrueDent Magenta TrueDent White TrueDent Yellow TrueDent Clear

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility