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Dura-Crown is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. Dura-Crown is used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and bridge restorations. Dura-Crown can also be used for the fabrication of artificial teeth and temporary crowns & bridges.

The product should be used in combination with SHINING3D printer. It is stored in 500ml HDPE bottle. The product is a liquid photo-curable material, which is produced by free radical polymerization of oligomers triggered by a photoinitiator contained in the resin. Automated printing of the resin in multiple layers, each light-cured before adding next layer, are post cured in the cure device. The product is intended exclusively for professional dental work.

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Denture Base Resin is a light-curable polymerizable resin intended to be used for the fabrication of full and partial removable dentures. Fabrication of denture base Resin requires a digital denture file, 3D printer and post-curing unit.

Denture Base Resin is a liquid light-curable material. The product should be used in combination with the 3D printer. Printer and resin must be optimized to each other in order to get complete and precise printed parts. The 3D printer and the post-curing unit of SHINING3D make use of a light source to polymerize the Denture Base Resin.

I am sorry, but the provided text does not contain information about the acceptance criteria and study that proves the device meets the acceptance criteria in the format you requested, as it pertains to a medical device's AI/algorithm performance.

The document is a 510(k) premarket notification for a Denture Base Resin (a material used for making dentures). It focuses on:

• Substantial Equivalence: Comparing the new resin to an existing predicate resin based on material composition, intended use, manufacturing process, and various performance and biocompatibility tests for dental materials.
• Non-Clinical Performance Tests: These tests are for the physical and biological properties of the resin material itself, such as mechanical properties according to ISO 20795-1, color stability according to ISO 7491, biocompatibility according to ISO 10993-1 and ISO 7405, and shelf-life.
• No Clinical Study: The document explicitly states, "No clinical study is included in this submission."

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/algorithm, nor can I answer questions about sample sizes for test sets, data provenance, ground truth establishment by experts, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided text which describes a physical dental material, not an AI medical device.

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