BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    P50 Series Dental Operative Unit and Accessories

    K Number: K171872 · Decision Apr 26, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    2
    Review Days
    307

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    Basic Information

    Device Name
    P50 Series Dental Operative Unit and Accessories
    K Number
    K171872
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pelton & Crane
    Date Received
    June 23, 2017
    Decision Date
    April 26, 2018
    Product Code
    EIA
    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
    EIA Unit, Operative Dental

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