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510(k) Data Aggregation

    K Number
    K111250
    Device Name
    DRY MOUTH MOUTHWASH
    Manufacturer
    DR. FRESH, INC.
    Date Cleared
    2012-04-27

    (359 days)

    Product Code
    LFD
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DR. FRESH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relieves the symptoms of dry mouth, while moisturizing and lubricating oral dryness.
    Device Description
    Dr. Fresh Dry Mouth Mouthwash is a specifically formulated artificial saliva substitute which contains moisturizers, humectants and patent pending salivary enzymes that have lubricating, moisturizing and soothing properties to relieve the symptoms of Dry Mouth. The liquid product is supplied in 1.5 oz, 16 oz and 33.8 oz PET bottles.
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    K Number
    K110888
    Device Name
    ABSOLUTE WHITE LIGHT
    Manufacturer
    DR. FRESH, INC.
    Date Cleared
    2012-01-12

    (288 days)

    Product Code
    EEG
    Regulation Number
    872.6475
    Why did this record match?
    Applicant Name (Manufacturer) :

    DR. FRESH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Absolute White Light emits visible blue light in the 400 nanometer spectrum and is intended to provide a light source for bleaching teeth.
    Device Description
    The Absolute White Light is intended for use by the end consumer. The Absolute White Light is a battery operated, hand held device that contains a hun vosible light in the 400 nanometer spectrum, which can penetrate the tooth and activate the photoactive substances within the tooth yielding a minimal amount of heat. Built in safety features include automatic light shut off after two minutes and "Light Guard" that prevents light exposure to the user's eyes.
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