BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Carestream Dental LLC

    Reg #: 1226003 · FEI: 3002522649 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    108
    Establishment Types
    4
    Classifications
    10

    Registration Details

    Registration Name
    Carestream Dental LLC
    Registration Number
    1226003
    FEI Number
    3002522649
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3625 Cumberland Boulevard, Suite 700
    City
    Atlanta
    State
    GA
    ZIP
    30339
    Country
    US

    Regulatory Submissions

    510(k) Number
    K950532
    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

    Products

    Device Name Product Code
    Unit, X-Ray, Intraoral EAP
    System, X-Ray, Extraoral Source, Digital MUH
    X-Ray, Tomography, Computed, Dental OAS
    System, Image Processing, Radiological LLZ
    Unit, Operative Dental EIA
    Holder, Film, X-Ray EGZ
    Unit, X-Ray, Extraoral With Timer EHD
    Screen, Intensifying, Radiographic EAM
    Analyzer, Medical Image MYN
    Film, Radiographic IWZ

    Proprietary Names

    RVG 6200 RVG 5200 RVG 142 RIOSensor+ S2 DENTRA III CS 7600 SLOT PANEL CS 7600 SCAN&GO DEVICE CS 7600 CS 7200 CS 9300 CEPHALOSTAT CS 9300 Select CS 9300C CS 9300C Select RVG CONNECT RVG 6500 CS OMS Imaging software CS Orthodontic Imaging Software Swissmeda powered by Carestream Dental CS 1500 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 2100 CS 2200 CS 8100SC 3D Access CS 8100 3D Access CS 8100SC 3D CS 8100 3D SCAN CEPH CS 8200 3D Access CS 8200 3D CS 8100 Access CS 8100 CS 7600 Smart Plate Imaging Plate CSD Smart Plate CS Imaging (Version 8) Logicon Caries Detector CS 9600 Scan Ceph CS 1200

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device