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

    HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE

    K Number: K080682 · Decision Sep 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    2
    Review Days
    185

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    Basic Information

    Device Name
    HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE
    K Number
    K080682
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Handpiece Headquarters, Inc. - Hpr, Inc.
    Date Received
    March 10, 2008
    Decision Date
    September 11, 2008
    Product Code
    EFB
    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
    EFB Handpiece, Air-Powered, Dental

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    Other Clearances by Handpiece Headquarters, Inc. - Hpr, Inc.

    K Number Device Name
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