BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

    K Number: K160367 · Decision Jul 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    481
    Applicant Total
    1
    Review Days
    169

    Basic Information

    Device Name
    Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
    K Number
    K160367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nissin-Metec China Co., Ltd.
    Date Received
    February 9, 2016
    Decision Date
    July 27, 2016
    Product Code
    EIH
    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
    EIH Powder, Porcelain

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