BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇾 Malaysia

    SILVERFIL

    K Number: K053114 · Decision Nov 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    73
    Applicant Total
    1
    Review Days
    8

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    Basic Information

    Device Name
    SILVERFIL
    K Number
    K053114
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3070
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dunia Perwira Manufacturing Sdn. Bhd.
    Date Received
    November 7, 2005
    Decision Date
    November 15, 2005
    Product Code
    EJJ
    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
    EJJ Alloy, Amalgam

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