BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Prettau, ICE, Z-White zirconia blanks

    K Number: K183304 · Decision Apr 4, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    481
    Applicant Total
    8
    Review Days
    127

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    Basic Information

    Device Name
    Prettau, ICE, Z-White zirconia blanks
    K Number
    K183304
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zirkonzahn Srl
    Date Received
    November 28, 2018
    Decision Date
    April 4, 2019
    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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