(55 days)
Wirobond C is a non-Precious dental casting alloy to make full crowns and copings for porcelain fused to metal dental restorations.
Wirobond C is a non-Precious dental casting alloy.
The provided document is a 510(k) clearance letter from the FDA for a dental alloy, Wirobond C. It does not contain any information about acceptance criteria, device performance studies, or AI/software algorithm assessments.
Therefore, I cannot provide a response to your request, as the necessary information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details is completely absent from the provided text.
This document is solely focused on the regulatory clearance of a physical medical device (dental alloy) and confirms its substantial equivalence to a predicate 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.