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

    RASTRONICS PORTAREM 20

    K Number: K902287 · Decision Aug 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    626
    Applicant Total
    5
    Review Days
    79

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    Basic Information

    Device Name
    RASTRONICS PORTAREM 20
    K Number
    K902287
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Rastronics USA, Inc.
    Date Received
    May 22, 1990
    Decision Date
    August 9, 1990
    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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