(56 days)
PlatinLloyd 100 is a crown and bridge type 4 casting alloy. It is a medical device in accordance with Regulation 95712 BBC. Guarder segulaiton requirements are met.
AuroLloyd KF
The provided FDA 510(k) clearance letter and associated documents for the "AuroLloyd® KF" device (K983080) do not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
The documents indicate that the device, "PlatinLloyd 100," is a crown and bridge type 4 casting alloy and is being cleared based on its substantial equivalence to a legally marketed predicate device. The clearance is based on the device meeting CE seal requirements in accordance with Regulation 957/2 BBC (which seems to be a European regulation, potentially 93/42/EEC concerning medical devices or a similar standard, given the context of "Annex IX and CE seal").
Therefore, I cannot provide the requested information as it is not present in the given text. The FDA 510(k) process for substantial equivalence often relies heavily on comparison to an existing predicate device rather than demanding new clinical trials with detailed performance criteria and statistical studies for certain classes of devices, especially materials like dental alloys.
§ 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.