(33 days)
This is a white Type III Crown & Bridge alloy for single & ¾ crowns, inlays, veneer crowns, and short span bridges.
Jel-20 is a white Type III Crown & Bridge alloy.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for a dental alloy, stating its substantial equivalence to a predicate device. It does not include a scientific study report or clinical trial results. Therefore, I cannot fulfill your request based on this 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.