(147 days)
This device is a nonprecious, copper-aluminum (plus gold) based casting alloy for use in the construction of cast dental crown and bridge prosthetic devices, such as fullmetal-coverage (FMC) crowns and bridgework, inlays/onlays, posts and cores, and metal sub-structures for polymer crown and bridge resins.
nonprecious, copper-aluminum (plus gold) based casting alloy
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy device (NPG+2). It confirms the device's substantial equivalence to a legally marketed predicate device.
However, this document does NOT contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input.
§ 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.