BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Nanova Sealant

    K Number: K171330 · Decision Sep 8, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    130
    Applicant Total
    8
    Review Days
    126

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    Basic Information

    Device Name
    Nanova Sealant
    K Number
    K171330
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3765
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanova Biomaterials, Inc.
    Date Received
    May 5, 2017
    Decision Date
    September 8, 2017
    Product Code
    EBC
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EBC Sealant, Pit And Fissure, And Conditioner

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