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

    Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series

    K Number: K253973 · Decision Jan 9, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    481
    Applicant Total
    10
    Review Days
    29

    Basic Information

    Device Name
    Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series
    K Number
    K253973
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.6660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Liaoning Upcera Co., Ltd.
    Date Received
    December 11, 2025
    Decision Date
    January 9, 2026
    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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