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

    POWER BLOCK

    K Number: K983227 · Decision Dec 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    110
    Registration Numbers
    110
    Same Product Code
    32
    Applicant Total
    5
    Review Days
    87

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    Basic Information

    Device Name
    POWER BLOCK
    K Number
    K983227
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6300
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kreativ, Inc.
    Date Received
    September 15, 1998
    Decision Date
    December 11, 1998
    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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