BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)

    K Number: K260830 · Decision Mar 18, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    137
    Applicant Total
    2
    Review Days
    5

    Basic Information

    Device Name
    APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
    K Number
    K260830
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3260
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sangi Co., Ltd.
    Date Received
    March 13, 2026
    Decision Date
    March 18, 2026
    Product Code
    LBH
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LBH Varnish, Cavity

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    Other Clearances by Sangi Co., Ltd.

    K Number Device Name
    K220419 Apapro Desensitizer