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510(k) Data Aggregation

    K Number
    K260830

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-18

    (5 days)

    Product Code
    Regulation Number
    872.3260
    Panel
    Dental
    Age Range
    0 - 150
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    APAPRO Desensitizer Homecare is a fluoride-free daily-use cleaning toothpaste that also provides relief from tooth sensitivity due to cold, heat, acids, sweets or contact, through its action of occluding dentin tubules through surface coating, promoting an environment conducive to remineralization.

    Device Description

    APAPRO Desensitizer Homecare is a fluoride-free daily-use toothpaste device that contains hydroxyapatite, the main component of teeth, as its active ingredient. The formulation is designed to clean teeth as well as to help restore a tooth's hydroxyapatite structure through surface coating, promoting an environment conducive to remineralization, which results in physical occlusion of exposed dentin tubules, providing relief from tooth hypersensitivity. The hydroxyapatite deposited into the dentin tubules by APAPRO Desensitizer Homecare acts as a template for the further deposition of large amounts of calcium and phosphate ions, promoting crystal integrity and growth.

    AI/ML Overview

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