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510(k) Data Aggregation

    K Number
    K253778

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-02-27

    (93 days)

    Product Code
    Regulation Number
    N/A
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Allday Moisturizing Rinse is indicated to provide relief from dry mouth, clean, refresh, and soothe oral tissues. It is recommended to be used by people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth.

    Allday Moisturizing Rinse is indicated for rapid relief of dry mouth symptoms, to provide a protective coating inside the mouth and to help control bad breath.

    A mouth rinse that quickly reduces mouth discomfort, oral malodor and other symptoms of dry mouth.

    Device Description

    Allday® Moisturizing Rinse is an oral moisturizing rinse that patients will use to alleviate dry mouth symptoms. They will swish or rinse with the product for 30 seconds and spit/expectorate into the sink. The rinse will coat the inside of the mouth for a period of time and relieve symptoms of dry mouth such as oral malodor, discomfort, difficulties eating or speaking.

    AI/ML Overview

    N/A

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