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

    MINIDAM II

    K Number: K921771 · Decision Sep 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    110
    Registration Numbers
    110
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    157

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    Basic Information

    Device Name
    MINIDAM II
    K Number
    K921771
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6300
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Delsan Dental Systems
    Date Received
    April 13, 1992
    Decision Date
    September 17, 1992
    Product Code
    EIE
    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
    EIE Dam, Rubber

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    Other Clearances by Delsan Dental Systems

    K Number Device Name
    K921117 MINIDAM