(32 days)
Indications for Use: D-Sign is to be used with conventional feldpathic porcelains. Also recommended for 3/4 crowns, telescop crowns, conus porcerains. Inco recoments, short and long span bridges, PFM crowns.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental device called "D-Sign IV". The letter states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or specifics about ground truth for training or testing sets. These details are typically found in the substantial equivalence report or technical documentation submitted with the 510(k) application, not in the clearance letter itself.
Therefore, I cannot provide the requested information based on the given input. The document confirms market clearance based on substantial equivalence, but it does not detail the technical study results or performance metrics.
§ 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.