(63 days)
Portadur P2 is a gold casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Inlays/ Onlays - Crowns - Short span bridges - Long span bridges - Removable partials and can be used for - Telescopic and milling work In addition Portadur P2, in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of identical or comparable alloys are joined to form dental restorations.
Portadur P 2 is an extra-hard gold casting alloy with high contents of noble metals (75.1%), 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. In addition, it is suitable for telescopic and milling work as well as for laser welding. For this application it will be delivered in the shape of laser welding wires. Portadur P 2 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
The provided text is for a 510(k) premarket notification for a dental alloy, not an AI/ML medical device. Therefore, the information requested about acceptance criteria, study details, ground truth, and AI/ML specific aspects (like MRMC studies, human readers, training sets) is not applicable to this document.
Dental alloys are evaluated based on their material properties and compliance with established international standards, not on performance metrics typically associated with AI/ML algorithms.
The document states: "Portadur P 2 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices."
This indicates that the acceptance criteria for this device are demonstrated by its compliance with the specified international standard for dental casting golds and the relevant European directive for medical devices. The study proving this would involve laboratory testing of the alloy's physical, chemical, and biological properties to ensure it meets the requirements of ISO 1562. However, the details of such a study (sample size, specific test results, etc.) are not provided in this summary.
§ 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.