(56 days)
BegoPal 300 is a crown and bridge metal to ceramic type 4 alloy. It is a medical device in accordance with Regulation 93/42 EEG. Class IIa according to Annex IX. The CE seal is a declaration by the manufacturer that the regulation requirements are met.
BegoPal 300 is a crown and bridge metal to ceramic type 4 alloy.
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental alloy called "BegoPal 300". It states that the device is substantially equivalent to legally marketed predicate devices and is classified as a Class II medical device.
However, this document does not contain any information about acceptance criteria, device performance, a specific study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established. It is purely a regulatory approval document.
Therefore, I cannot fulfill your request for the detailed description of acceptance criteria and the study proving device performance based on the provided input.
§ 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.