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510(k) Data Aggregation

    K Number
    K201937
    Device Name
    Ceramir Restore QuikCap
    Manufacturer
    Date Cleared
    2020-11-13

    (123 days)

    Product Code
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Doxa Dental AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ceramir® Restore QuikCap is a self-curing bioceramic restorative material of glass ionomer type.
    Device Description
    Ceramir Restore QuikCap is a self-curing bioceramic restorative material of glass ionomer type. It is a hybrid between a glass ionomer cement and a ceramic cement based on calcium aluminate. The material is radiopaque. Ceramir Restore QuikCap contains a ceramic powder and a liquid, separated in different compartments, in a plastic capsule. The capsule is activated just before use, allowing the powder and liquid to blend in the capsule. The content is mixed by using a high-frequency oscillating or rotating capsule mixer. A capsule applicator, "Ceramir Applicator 2", is needed to extrude the mixed material into the tooth cavity. The applied cement is formed using conventional tooth filling techniques. After setting, the material is ready for finishing and dry polishing. The cement is available in shade A2 and is designated opaque (Vita shade guide).
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    K Number
    K113040
    Device Name
    CERAMIR CROWN & BRIDGE
    Manufacturer
    Date Cleared
    2011-12-28

    (77 days)

    Product Code
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOXA DENTAL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ceramir Crown & Bridge is intended for the permanent cementation of - Metal and Porcelain Fused to Metal Crowns and Bridges . - Gold inlays and onlays . - Cast or prefabricated metal posts . - Cast of prefabriodical metally provins and bridges suitable for conventional ● righ Strength og. zirconia, alumina, and lithium disilicate)
    Device Description
    Not Found
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    K Number
    K081405
    Device Name
    XERACEM
    Manufacturer
    Date Cleared
    2008-08-21

    (94 days)

    Product Code
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOXA DENTAL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XeraCem is intended for the permanent cementation of - Porcelain Fused to Metal Crowns and Bridges . - Metal (gold etc.) crowns and bridges . - Gold inlays and onlays . - . Prefabricated metal and cast posts - . Prefabricated metal provisional crowns - . All-zirconia or all-alumina ceramic crowns and bridges
    Device Description
    XeraCem is a hybrid between glass ionomer cement and ceramic cement based on calcium aluminate. It combines the advantages of glass ionomer cements with those of calcium aluminum based cements. XeraCem is a hand mixed cement and consists of a powder (XeraCem powder) and a liquid (XeraCem liquid).
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