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Visalys® CemCore is a dual-curing, adhesive cementation and core build-up composite, which is intended to be used for: a) Permanent cementation of · crowns, bridges, inlays, veneers and adhesive bridges made of metal, ceramic, composite, hybrid and oxide ceramics • root posts and indirect core build-ups b) Composite for · adhesive core build-ups Visalys® CemCore Try In Paste is a water-soluble polyethylene glycol paste for shade matching: · To check the shade selected prior to permanent cementation with Visalys® CemCore. · For covering the cement joint to reduce a layer of inhibition.

Visalys® CemCore is a dual-curing composite containing fluoride for adhesive cementation of indirect restorations and root posts and can be used to fabricate radiopaque core build-ups and abutment fillings. Due to the Active-Connect-Technology (ACT) Visalys® CemCore includes an additional initiator system for the optimization of the adhesive bond. BPA or BPA precursors are not used in the manufacturing process of this device. Visalys® CemCore shall only be used in combination with self-etching Visalys® Tooth Primer. Visalys® Restorative Primer is recommended as the primer for the restoration surfaces. Visalys® CemCore is easy to use and has high adhesive strength and good flowability with stable consistency. Visalys® CemCore is offered in the shades Universal (A2/A3), Dark (A4), Opaque, Bleach and Translucent. The paste should be mixed and dispensed directly from a double syringe with the corresponding mixing tips blue (MLø 3.2 mm). Visalys® CemCore Try in Paste serves to simulate the shade effect of the selected Visalys® CemCore shade on ceramic restorations and for covering the cement joint to reduce a layer of inhibition. The water-soluble paste corresponds in shade and translucence with the completely cured Visalys® CemCore. Visalys® CemCore Try In Paste is offered in the shades Universal (A2/A3), Dark (A4), Opaque, Bleach and Translucent. The paste is dispensed from a syringe and syringe tip.

The provided text describes a 510(k) premarket notification for a dental device, Visalys® CemCore and Visalys® CemCore Try In Paste. It details the device's characteristics, indications for use, and a comparison to predicate devices, along with non-clinical performance testing results.

However, the document does not contain information about a study proving the device meets specific acceptance criteria related to AI/algorithm performance, nor does it refer to human reader studies, ground truth establishment by experts, or training/test set data for an AI system. The assessments are based on bench testing for mechanical properties, biocompatibility, and visual comparisons for shade consistency, all against established ISO or ASTM standards, or internal methods.

Therefore, I cannot fulfill the request as it pertains to AI/algorithm performance and human expert studies because such information is not present in the provided text. The device is a dental material, not an AI-powered diagnostic or assistance tool.

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