(45 days)
Ceraloy alloy is intended to be used by dentists and dental laboratories for the fabrication of custom made dental devices such as onlays, ¼ crowns, veneers, inlays long and short span bridgework and PFM restorations.
Ceraloy
It appears the provided text is a 510(k) clearance letter from the FDA for a dental alloy named "Ceraloy." This type of document primarily confirms that a new device is "substantially equivalent" to a legally marketed predicate device.
This document does NOT contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth adjudication, or any details typically associated with AI/ML device evaluations.
The FDA 510(k) clearance process for a material like a dental alloy focuses on comparing its characteristics (e.g., composition, mechanical properties, biocompatibility) to an already approved predicate device, rather than conducting new clinical performance studies as would be required for a novel diagnostic or AI-driven device.
Therefore, I cannot extract the requested information based on the provided text. To answer your questions, I would need a document detailing the results of a performance study for an AI/ML medical device.
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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.