BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Customized Abutment and Screw

    K Number: K242768 · Decision Sep 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    5
    Review Days
    354

    Basic Information

    Device Name
    Customized Abutment and Screw
    K Number
    K242768
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chengdu Besmile Medical Technology Co., Ltd.
    Date Received
    September 13, 2024
    Decision Date
    September 2, 2025
    Product Code
    NHA
    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
    NHA Abutment, Implant, Dental, Endosseous

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