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Dentona vivatemp and Dentona flexisplint (powder/liquid) are heat cured, moldable, acrylic compound systems for use in the fabrication of dental appliances such as splints, night guards, mouthquards and bruxism appliances.

The optimill memosplint blank and the optimill memosplint version S blank are discs intended for the fabrication of dental appliances such as splints, night guards and bruxism appliances using CAD/CAM milling machines.

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I apologize, but the provided text is a 510(k) clearance letter from the FDA for several dental materials (dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S).

This document does not contain any information about acceptance criteria, study details, device performance metrics, sample sizes, ground truth establishment, or expert qualifications. It only clarifies that these devices are cleared for specific dental applications based on substantial equivalence to predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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