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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    PORTA OP SOLDER M-1

    K Number: K022452 · Decision Sep 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    626
    Applicant Total
    45
    Review Days
    47

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    Basic Information

    Device Name
    PORTA OP SOLDER M-1
    K Number
    K022452
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wieland Dental + Technik GmbH & Co. KG
    Date Received
    July 26, 2002
    Decision Date
    September 11, 2002
    Product Code
    EJT
    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
    EJT Alloy, Gold-Based Noble Metal

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