(47 days)
W-5 alloy intended to be used for onlay, ¾ crows, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns.
Not Found
The provided text describes a 510(k) premarket notification for a dental alloy, W-5. It is a letter from the FDA to Ivoclar Vivadent, Incorporated, stating that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information regarding acceptance criteria, device performance testing, or study details such as sample size, data provenance, expert consensus, adjudication methods, or comparative effectiveness studies.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. This type of information is typically found in the 510(k) submission itself or in a summary of safety and effectiveness, neither of which is present in the provided FDA letter.
§ 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.