BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SANI-PIKS DENTAL HAND INSTRUMENT

    K Number: K895985 · Decision Jan 10, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    71
    Applicant Total
    1
    Review Days
    89

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    Basic Information

    Device Name
    SANI-PIKS DENTAL HAND INSTRUMENT
    K Number
    K895985
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Bison-Lee Co.
    Date Received
    October 13, 1989
    Decision Date
    January 10, 1990
    Product Code
    EKJ
    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
    EKJ Burnisher, Operative

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