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510(k) Data Aggregation

    K Number
    K111291
    Device Name
    AIDITE ZIRCONIA DENTAL CERAMICS
    Manufacturer
    QINHUANGDAO AIDITE HIGH-TECHNICAL CERAMICS CO, LTD
    Date Cleared
    2011-07-20

    (75 days)

    Product Code
    EIH, REG
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    QINHUANGDAO AIDITE HIGH-TECHNICAL CERAMICS CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aidite Zirconia Dental Ceramics are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
    Device Description
    Aidite Zirconia Dental Ceramics are derived from zirconia powder that has been processed via uni-aixial die pressing, followed by iso-static pressing, to achieve various shapes of uniform density and distribution. The ceramic blocks can be fabricated into various prosthetic dental devices.
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