(51 days)
BegoPal is a crown and bridge metal to ceramic type 4 alloy. It is a medical device in accordance with 93/42 EEC. Class IIa according to Annex IX.
BegoPal is a crown and bridge metal to ceramic type 4 alloy.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that demonstrates a device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a dental alloy named BegoPal, indicating its substantial equivalence to a predicate device. It discusses regulatory matters such as classification, general controls, and marketing authorization.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on the provided text.
§ 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.