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

    TRAUS Air Dental Handpiece

    K Number: K221741 · Decision Feb 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    18
    Review Days
    252

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    Basic Information

    Device Name
    TRAUS Air Dental Handpiece
    K Number
    K221741
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Saeshin Precision Co., Ltd.
    Date Received
    June 15, 2022
    Decision Date
    February 22, 2023
    Product Code
    EFB
    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
    EFB Handpiece, Air-Powered, Dental

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