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510(k) Data Aggregation

    K Number
    K231142
    Device Name
    Temporis, Irix Plus
    Manufacturer
    Date Cleared
    2024-04-25

    (370 days)

    Product Code
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    DWS s.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Temporis and Irix Plus are light-curing materials intended for fabricating indirect restorative for both anterior and posterior restorations, such as inlays, onlays, veneers, anterior or posterior crowns and bridges. Temporis is used for fabricating temporary dental restorations, Irix Plus is used for fabricating permanent dental restorations.
    Device Description
    Temporis and Irix Plus are methacrylate-based resins used to manufacture high-precision threedimensional custom-made dental restorations based on scanned images of the mouth of the patient. They are liquid resins that are subjected to solidification by laser induced polymerization - that is the process where monomers in liquid phase combine together to convert into polymers in solid phase - using dedicated 3D printing equipment working on the principle of stereolithography. The shape of the dental restoration is determined by a 3D stereolithographic drawing. Temporis is used for manufacturing temporary dental restorations - such as inlays, onlays, veneers, anterior or posterior crowns and bridges (up to one pontic) - prior to the application of a permanent restoration. Irix Plus is used for manufacturing permanent dental restorations used to replace a decayed portion of tooth structure, like inlays, onlays, veneers, anterior or posterior crowns and bridges (up to one pontic).
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