BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)

    K Number: K233122 · Decision Apr 30, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    1
    Review Days
    216

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    Basic Information

    Device Name
    High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)
    K Number
    K233122
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Litu Tech , Ltd.
    Date Received
    September 27, 2023
    Decision Date
    April 30, 2024
    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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