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

    Dental Zirconia Ceramic

    K Number: K250811 · Decision Apr 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    471
    Applicant Total
    11
    Review Days
    25

    Basic Information

    Device Name
    Dental Zirconia Ceramic
    K Number
    K250811
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.6660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aidite (Qinhuangdao) Technology Co., Ltd.
    Date Received
    March 17, 2025
    Decision Date
    April 11, 2025
    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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