(71 days)
Artegral, and Polystar® Selection are intended for use as teeth in dentures.
Artegral, and Polystar® Selection preformed plastic teeth are prefabricated devices composed of polymethylmethacrylate and cross-linking co-polymers of methacrylic acid (IPN) intended for use as teeth in dentures.
Artegral, and Polystar® Selection preformed plastic teeth are prefabricated devices composed of polymethylmethacrylate and cross-linking co-polymers of methacrylic acid (IPN).
The provided text describes a 510(k) premarket notification for "Artegral and Polystar Selection Performed Plastic Denture Teeth." This is a regulatory submission for a medical device, and the information contained does not directly correspond to the requested details about acceptance criteria and a study proving a device meets those criteria in the context of an AI/algorithm-based medical device.
The document discusses the intended use of the denture teeth, their chemical composition, and states that "Performance and safety testing activities were conducted against recognized standards to establish the reliability characteristics of the new devices. Testing involved bench studies, and biocompatibility tests." However, it does not provide specific acceptance criteria, reported performance, or details of a study in the format requested for an AI/algorithm.
Therefore, I cannot provide the requested table and study details. This document pertains to a physical dental device and its regulatory clearance, not an AI-driven one with specific performance metrics like sensitivity, specificity, or reader studies.
§ 872.3590 Preformed plastic denture tooth.
(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.