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

    ABSOLUTE WHITE LIGHT

    K Number: K110888 · Decision Jan 12, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    288

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    Basic Information

    Device Name
    ABSOLUTE WHITE LIGHT
    K Number
    K110888
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6475
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dr. Fresh, Inc.
    Date Received
    March 30, 2011
    Decision Date
    January 12, 2012
    Product Code
    EEG
    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
    EEG Heat Source For Bleaching Teeth

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