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510(k) Data Aggregation

    K Number
    K222891
    Device Name
    Dental Desensitizer
    Manufacturer
    Guangzhou Beogene Biotech Co., Ltd
    Date Cleared
    2023-05-25

    (244 days)

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

    Guangzhou Beogene Biotech Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dental Desensitizer is a colorless transparent gel that is applied to the sensitive part of the tooth to form a film, sealing the exposed dentin tubules and relieving dentin allergy. The product is used either by a dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.
    Device Description
    Dental Desensitizer is a sustained release, 3% potassium nitrate and 0.11% weight fluoride ion, viscous gel. This product is designed to be used together with a custom-fabricated tray.
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