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

    Young INFINITY Cordless Handpiece System

    K Number: K171377 · Decision Aug 20, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    16
    Review Days
    467

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    Basic Information

    Device Name
    Young INFINITY Cordless Handpiece System
    K Number
    K171377
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Young Dental Manufacturing Co. 1, LLC
    Date Received
    May 10, 2017
    Decision Date
    August 20, 2018
    Product Code
    EKX
    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
    EKX Handpiece, Direct Drive, Ac-Powered

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