(70 days)
Porta Aurium is a universal gold-based dental alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Inlays/ Onlays, Partial crowns, Crowns, Short span bridges, Long span bridges, Removable partials and can be used for Telescopic and milling work. Porta Aurium can be veneered with low-fusing dental ceramics with high expansion as well as with dental-composites.
Porta Aurium is an extra-hard universal alloy with high contents of noble metals (80,5%), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and therefore suitable for telescopic and milling work. Porta Aurium is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Porta Aurium can be veneered with low-fusing dental ceramics with high expansion and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations.
The provided text is related to a 510(k) premarket notification for a dental alloy named Porta Aurium. It describes the device, its intended use, and its classification, and states that it has been deemed substantially equivalent to a predicate device.
However, the document does not contain information about acceptance criteria, a study proving device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone AI performance).
Therefore, I cannot provide the requested information from the given text. The text is a regulatory submission for a medical device (a dental alloy), not a scientific study reporting on the performance of a diagnostic or AI-based device.
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.