BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM

    K Number: K971894 · Decision Aug 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    60
    Applicant Total
    238
    Review Days
    90

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    Basic Information

    Device Name
    KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM
    K Number
    K971894
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2030
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eastman Kodak Company
    Date Received
    May 22, 1997
    Decision Date
    August 20, 1997
    Product Code
    LMA
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LMA Digitizer, Image, Radiological

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