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

    PERIO CONTROL II

    K Number: K972642 · Decision Jan 26, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    195

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    Basic Information

    Device Name
    PERIO CONTROL II
    K Number
    K972642
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Estrad B.V.
    Date Received
    July 15, 1997
    Decision Date
    January 26, 1998
    Product Code
    EIK
    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
    EIK Carver, Wax, Dental

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