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510(k) Data Aggregation

    K Number
    K192262
    Device Name
    Dental Zirconia Blocks
    Date Cleared
    2020-05-29

    (282 days)

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

    De Corematrix Co.Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dental Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers. All Blocks are processed through dental laboratories or by dental professionals.
    Device Description
    The proposed device, Dental Zirconia Blocks, are derived from zirconia powder, usually using CAD / CAM (computer aided design / computer aided manufacturing) method of making all-ceramic restorations such as crowns.bridges.veneers.inlay, with high strength, hardness, good resistance to fracture toughness and wear resistance. They are available in different models that differ in various specification and color. Two main models for Dental Zirconia Block are CMW series and CMC series in which CMW series represents the White Zirconia(W1,W2 and W3) and the CMC series represents the Color Zirconia (A1,A2,A3,A3.5,A4,B1,B2, B3,B4,C1,C2,C3,C4,D1,D2,D3,D4,T1,T2 and T3). The white zirconia is composed of ZrO2+HfO2+YzOs and an additional inorganic pigment: Al₂O3 and Other oxide. The colour zirconia are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe2O3 +Pr2O3 +Er2O3. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs, that matches natural color of patient's teeth. The composition of the Dental Zirconia Blocks including the white zirconia and the colour zirconia conforms to ISO 13356:2015, Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials. The Dental Zirconia Blocks are provided as non-sterile.
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