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

    BEAM BRUSH/BEAM APP

    K Number: K121165 · Decision Jun 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    574
    Same Product Code
    48
    Applicant Total
    1
    Review Days
    65

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    Basic Information

    Device Name
    BEAM BRUSH/BEAM APP
    K Number
    K121165
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6855
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beam Technologies, LLC
    Date Received
    April 17, 2012
    Decision Date
    June 21, 2012
    Product Code
    EFW
    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
    EFW Toothbrush, Manual

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