BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hygienic Sheaths

    Reg #: 1226003 · FEI: 3002522649 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Carestream Dental LLC
    Registration Number
    1226003
    FEI Number
    3002522649
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3625 Cumberland Boulevard, Suite 700
    City
    Atlanta
    State
    GA
    ZIP
    30339
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190949

    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
    Dental Barriers And Sleeves PEM

    Proprietary Names

    Hygienic Sheaths CS 7600 Hygienic Sheaths

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility