(24 days)
Used for brazing dental alloys prior to porcelain application.
Not Found
The provided document is an FDA 510(k) clearance letter for a dental solder, DW 296 #15 Solder. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the context of an AI/algorithm-driven device.
The document is a regulatory approval, confirming that the device is substantially equivalent to a legally marketed predicate device for its intended use (brazing dental alloys prior to porcelain application). It focuses on the regulatory classification and general controls, rather than performance studies with acceptance criteria as typically seen for AI/ML medical devices.
Therefore, I cannot provide the requested information from this document. If this device were an AI-driven one, the 510(k) summary (which is a separate document often submitted with the clearance) would be a more likely place to find such details.
§ 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.