BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇭🇰 Hong Kong

    Disposable Prophy Angle

    K Number: K240950 · Decision May 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    72
    Applicant Total
    1
    Review Days
    415

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    Basic Information

    Device Name
    Disposable Prophy Angle
    K Number
    K240950
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pacific Care Limited
    Date Received
    April 8, 2024
    Decision Date
    May 28, 2025
    Product Code
    EGS
    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
    EGS Handpiece, Contra- And Right-Angle Attachment, Dental

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