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

    MICROLUX/BLU

    K Number: K072309 · Decision Nov 19, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    22
    Applicant Total
    7
    Review Days
    94

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    Basic Information

    Device Name
    MICROLUX/BLU
    K Number
    K072309
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Addent, Inc.
    Date Received
    August 17, 2007
    Decision Date
    November 19, 2007
    Product Code
    EAZ
    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
    EAZ Light, Operating, Dental

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