BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Oral Surgery Contra

    K Number: K211584 · Decision Aug 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    8
    Applicant Total
    40
    Review Days
    87

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    Basic Information

    Device Name
    Oral Surgery Contra
    K Number
    K211584
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nakanishi, Inc.
    Date Received
    May 24, 2021
    Decision Date
    August 19, 2021
    Product Code
    KMW
    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
    KMW Handpiece, Rotary Bone Cutting

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