BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    CS 8100 3D Access

    Reg #: 3014398772 · FEI: 3014398772 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Carestream Dental Technology Topco Limited
    Registration Number
    3014398772
    FEI Number
    3014398772
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Wiltron House, Rutherford Close
    City
    Stevenage Hertfordshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K133406

    Owner / Operator

    Firm Name
    Carestream Dental LLC
    Operator Number
    10056540
    Address
    3625 Cumberland Boulevard, Suite 700
    City
    Atlanta
    State
    GA
    Postal Code
    30339
    Country
    US
    Correspondent
    Raven Wildharber

    US Agent

    Business Name
    RA Mgr
    Contact Name
    Raven Wildharber
    Address
    3625 Cumberland Boulevard, Suite 700
    City
    ATL
    State
    GA
    ZIP
    30339
    Country
    US
    Email
    [email protected]
    Phone
    470 4818687

    Products

    Device Name Product Code
    System, X-Ray, Extraoral Source, Digital MUH
    X-Ray, Tomography, Computed, Dental OAS

    Proprietary Names

    CS 8100 3D Access CS 8100SC 3D CS 8100 3D SCAN CEPH CS 8100SC 3D Access CS 8200 3D Select CS 8200 3D CS 8200 3D Access Trophypan Excel Access Trophypan Excel Trophypan Excel 3D Select

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device