(64 days)
Bio Universal PKF alloy intended to be used for crowns, posts, short and long span bridges and PFM crowns.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental alloy, BioUniversal PKF. This type of document is a regulatory approval and does not contain information about acceptance criteria or a study proving device performance against such criteria.
The purpose of a 510(k) clearance is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through a new study with acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
To answer your request, I would need a different type of document, such as a clinical study report, a performance validation report, or a detailed product specification document that outlines specific performance criteria and the results of tests conducted to meet them.
§ 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.