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510(k) Data Aggregation

    K Number
    K220419
    Device Name
    Apapro Desensitizer
    Manufacturer
    Sangi Co, Ltd
    Date Cleared
    2022-02-16

    (2 days)

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

    Sangi Co, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    APAPRO Desensitizer is a fluoride-free paste that is indicated to provide relief from tooth hypersensitivity resulting from cold, heat, acids, sweets, or contact, through its action of dentin tubule occlusion.
    Device Description
    APAPRO Desensitizer is a fluoride-free tooth desensitizing paste that utilizes hydroxyapatite, the main component of teeth, as its active ingredient to relieve tooth sensitivity by physically occluding exposed dentin tubules. The hydroxyapatite deposited into dentin tubules by APAPRO Desensitizer then acts as a template for the further deposition of large amounts of calcium and phosphate ions, promoting crystal integrity and growth.
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