BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT

    K Number: K891186 · Decision Apr 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    37

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    Basic Information

    Device Name
    REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT
    K Number
    K891186
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.1820
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Benn Research , Ltd.
    Date Received
    March 6, 1989
    Decision Date
    April 12, 1989
    Product Code
    EHA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EHA Aligner, Beam, X-Ray