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

    PROANGLE DISPOSABLE PROPHY ANGLE

    K Number: K030603 · Decision Apr 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    72
    Applicant Total
    2
    Review Days
    48

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    Basic Information

    Device Name
    PROANGLE DISPOSABLE PROPHY ANGLE
    K Number
    K030603
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pac-Dent International (Suzhou), Ltd.
    Date Received
    February 25, 2003
    Decision Date
    April 14, 2003
    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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