BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    e-SDF

    K Number: K240619 · Decision Mar 6, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    1

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    Basic Information

    Device Name
    e-SDF
    K Number
    K240619
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3260
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kids-E-Dental Llp
    Date Received
    March 5, 2024
    Decision Date
    March 6, 2024
    Product Code
    PHR
    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
    PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish

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