BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Carestream Dental Technology Topco Limited

    Reg #: 3014398772 · FEI: 3014398772 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    102
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    Carestream Dental Technology Topco Limited
    Registration Number
    3014398772
    FEI Number
    3014398772
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    C/O Corporation Service Company (Uk) Limited, 5 Churchill Place, 10th Floor,
    City
    London London, City of
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K151837
    PMA Number
    P980025

    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
    Camera, Surgical And Accessories KQM
    System, Image Processing, Radiological LLZ
    Unit, X-Ray, Intraoral EAP
    System, X-Ray, Extraoral Source, Digital MUH
    Film, Radiographic IWZ
    Unit, X-Ray, Extraoral With Timer EHD
    X-Ray, Tomography, Computed, Dental OAS
    Analyzer, Medical Image MYN
    Holder, Film, X-Ray EGZ

    Proprietary Names

    Hygienic Sleeves Ear Cones Hygienic Sleeves 3D Bite Block Hygienic Sleeves Bite Block CS 1300 CS 3D Imaging Software RVG 6200 RVG 5200 RVG 142 RIOSensor+ S2 DENTRA III CS 8100 Access CS 8100 Imaging Plate CS 7600 Smart Plate CSD Smart Plate CS 2100 CS 2200 Swissmeda powered by Carestream Dental CS 8100SC Access CS 8100SC CS 8100SC 3D Access CS 8100 3D Access CS 8100SC 3D CS 8100 3D SCAN CEPH CS 8200 3D Access CS 8200 3D CS 9600 Scan Ceph CS 6200 CS Imaging (Version 8) Logicon Caries Detector 7600 Hygienic Sheaths size 4 7600 Hygienic Sheaths size 0 CGV53 HY469 Hygienic Sheaths size 0 CGL12 CGP09 CSD BDA33 CSD BDA34 HZ229 CIC70 HY515 CI903 HY567 Hygienic Sheaths size 1 Hygienic Sheaths CS 7200 Size 1 CI900 HZ236 CG913 HZ233 HZ230 JR868 CI906 CI905 HZ231 HY614 HY559 HZ235 CI897 CSD IX014 HY637 CI904 Hygienic Sheaths CS 7600 Size 1 HY619 HY507 HZ177 CGH99 HY513 CI901 Hygienic Sheaths CS 7600 Size 4 CSD IX016 Hygienic Sheaths CS 7600 Size 0 HZ232 CGV54 CSD IX015 HY467 Hygienic Sheaths CS 7600 Size 3 7600 Hygienic Sheaths size 3 HZ176 CGS50 CI902 CSD BDA32 7600 Hygienic Sheaths size 1 HZ234 CI898 CGP10 CGU20 CI899 HY356 7600 Hygienic Sheaths size 2 Hygienic Sheaths CS 7200 Size 0 Hygienic Sheaths CS 7600 Size 2 HY358 HY575 Hygienic Sheaths size 2 CGS58 HY581 HY512 CS 2500P

    Establishment Types

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