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510(k) Data Aggregation

    K Number
    K080631
    Device Name
    CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER
    Date Cleared
    2008-05-23

    (79 days)

    Product Code
    Regulation Number
    872.3520
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORAL HEALTH TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Cleanse. Freshen. Go. Aligner Cleansing Towelette is indicated for OTC use to remove oral debris and kill odor causing bacteria associated with removable dental appliances. Cleanse.Freshen.Go. Dental Appliance Cleanser is indicated for OTC use to remove oral debris and kill odor causing bacteria associated with removable dental appliances.
    Device Description
    Cleanse.Freshen.Go. Aligner Cleansing Towelette is a cleansing solution impregnated onto a towelette for cleaning oral debris from removable dental appliances. It does not require dilution or activation and the pre-moistened towelette is supplied in compact and portable foil laminated hermetically sealed packages. The ready-to-use product form enables faster and more frequent cleansing of removable dental appliances in locations otherwise found to be impractical with many denture cleanser alternatives. Cleanse.Freshen. Go. Dental Appliance Cleanser is a spray liquid cleansing solution for cleaning oral debris from removable dental appliances. It does not require dilution or activation and is supplied in a 2 oz. plastic pump spray bottle that is compact and portable. The ready-to-use product form enables faster and more frequent cleansing of removable dental appliances in locations otherwise found to be impractical with many denture cleanser alternatives.
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