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

    R-SI-LINE METAL-BITE

    K Number: K010926 · Decision Apr 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    2
    Review Days
    16

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    Basic Information

    Device Name
    R-SI-LINE METAL-BITE
    K Number
    K010926
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R-Dental Dentalerzeugnisse GmbH
    Date Received
    March 27, 2001
    Decision Date
    April 12, 2001
    Product Code
    ELW
    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
    ELW Material, Impression

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