(66 days)
Dental casting alloy for making dental restorations and appliances. is not indicated for use with don't a posislaw, (this ally
Silver-palladium based casting alloy
This document is a 510(k) summary for AURECAST 2 Dental casting alloy. It describes a comparison between the new device and a legally marketed predicate device (Jelenko Maestro) to demonstrate substantial equivalence, rather than providing a study proving the device meets specific acceptance criteria in the context of AI/software performance. Therefore, most of the requested information cannot be extracted directly from this document.
However, I can extract the information related to the comparison of properties that serves as the basis for demonstrating substantial equivalence.
Here's an analysis based on the document:
1. A table of acceptance criteria and the reported device performance
The document doesn't define explicit "acceptance criteria" in the typical sense of a software or medical device performance study (e.g., minimum sensitivity/specificity). Instead, it uses a comparison to a predicate device to establish substantial equivalence. The "acceptance criteria" can be inferred as the properties of the legally marketed predicate device, and the "reported device performance" are the properties of the AURECAST 2.
| Property | Acceptance Criteria (Jelenko Maestro) | Reported Device Performance (Aurecast 2) |
|---|---|---|
| Composition (weight%) | ||
| Gold (Au) | 3 | 1.9 |
| Silver (Ag) | 50 | 52.9 |
| Palladium (Pd) | 30 | 25.6 |
| Copper (Cu) | 15.9 | 17.3 |
| Zinc (Zn) | 1 | 1 |
| Tin (Sn) | 0 | 1 |
| Iridium (Ir) |
§ 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.