BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Accu-Dent XD Tray, Accu-Dent XD Syringe

    K Number: K143575 · Decision Apr 3, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    65
    Review Days
    107

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    Basic Information

    Device Name
    Accu-Dent XD Tray, Accu-Dent XD Syringe
    K Number
    K143575
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ivoclar Vivadent, Inc.
    Date Received
    December 17, 2014
    Decision Date
    April 3, 2015
    Product Code
    ELW
    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
    ELW Material, Impression

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