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510(k) Data Aggregation

    K Number
    K171542
    Device Name
    TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
    Date Cleared
    2018-03-16

    (294 days)

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

    Dr. Harold Katz, LLC (dba TheraBreath

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TheraBreath Dry Mouth Oral Rinse is intended for relief of dry mouth symptoms and is indicated for use to refresh, moisturize, lubricate and soothe the oral cavity, and alleviate discomfort due to dry mouth. TheraBreath Dry Mouth Lozenges are intended for relief of dry mouth symptoms, and are indicated for use to refresh, moisturize, lubricated, and soothe the oral cavity, and alleviate discomfort due to dry mouth.
    Device Description
    TheraBreath Dry Mouth Oral Rinse and TheraBreath Dry Mouth Lozenges are specifically formulated as an artificial saliva substitute with moisturizers, humectants and salivary enzymes with lubricating, moisturizing and soothing properties to relieve the symptoms of dry mouth. In addition. TheraBreath Dry Mouth Lozenges continuously moisten the mouth to relieve the symptoms of Dry Mouth and to refresh breath. TheraBreath Dry Mouth Oral Rinse and TheraBreath Dry Mouth Lozenges are sugar-free, alcohol-free, and gluten-free. TheraBreath Dry Mouth Oral Rinse is packaged in 16 ounce size bottles and is Tingling Mint flavored. TheraBreath Dry Mouth Lozenges are Mandarin Mint flavored and are sold in boxes of 24, 72, or 100 lozenges.
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