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

    ROS-TR SYSTEM

    K Number: K873143 · Decision Sep 11, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    2
    Review Days
    32

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    Basic Information

    Device Name
    ROS-TR SYSTEM
    K Number
    K873143
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn
    Date Received
    August 10, 1987
    Decision Date
    September 11, 1987
    Product Code
    DZE
    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
    DZE Implant, Endosseous, Root-Form

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    Other Clearances by Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn

    K Number Device Name
    K884140 ROS-TR SYSTEM