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

    PiezoImplant System

    K Number: K211872 · Decision Oct 12, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    482

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    Basic Information

    Device Name
    PiezoImplant System
    K Number
    K211872
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rex Implants, Inc.
    Date Received
    June 17, 2021
    Decision Date
    October 12, 2022
    Product Code
    NRQ
    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
    NRQ Blade-Form Endosseous Dental Implant

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