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

    EtchPro Etching Gel

    K Number: K200462 · Decision Sep 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    418
    Applicant Total
    11
    Review Days
    190

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    Basic Information

    Device Name
    EtchPro Etching Gel
    K Number
    K200462
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Belport Company, Inc., Gingi-Pak
    Date Received
    February 25, 2020
    Decision Date
    September 2, 2020
    Product Code
    KLE
    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
    KLE Agent, Tooth Bonding, Resin

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