BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇰🇷 South Korea

    K5 Cart, K5 Mount, K5 Swing

    K Number: K251491 · Decision Jul 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    1
    Review Days
    64

    Basic Information

    Device Name
    K5 Cart, K5 Mount, K5 Swing
    K Number
    K251491
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osstem Implant Company., Ltd. Chair Business
    Date Received
    May 14, 2025
    Decision Date
    July 17, 2025
    Product Code
    EIA
    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
    EIA Unit, Operative Dental

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