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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.

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).

This document is a 510(k) summary for DWS s.r.l.'s Temporis and Irix Plus dental resin materials, demonstrating their substantial equivalence to a predicate device. It is not a document that describes the acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device where the performance is measured by metrics like sensitivity, specificity, or AUC based on expert reads.

The information provided describes the regulatory process for a dental material (resin) that is used in 3D printing to fabricate dental restorations. The "performance testing" described refers to compliance with ISO standards for dental materials, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, including:

• A table of acceptance criteria and reported device performance (in terms of AI/ML metrics).
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

This document focuses on the material's physical, chemical, and biocompatibility properties relative to a predicate device, not on AI/ML performance.

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