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510(k) Data Aggregation

    K Number
    K140481
    Device Name
    COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH
    Manufacturer
    COLGATE-PALMOLIVE COMPANY
    Date Cleared
    2014-06-05

    (99 days)

    Product Code
    LBH, CLA
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLGATE-PALMOLIVE COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the management of sensitive teeth. Provides relief from painful sensitivity of teeth to cold, heat, acids, sweets, or contact. Desensitizes teeth for lasting relief.
    Device Description
    Colgate® Desensitizing Mouthwash (CDMW) is an oral rinse. The components of CDMW physically form a thin film that acts like a seal, thereby physically restricting fluid movement through the dentin tubules and preventing external stimuli from triggering a pain response.
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