(34 days)
Gold Core 55 is a Type IV, high noble, yellow alloy to be used for inlays, onlays, single crown briges, implant superstructures and substrate for low wear products and other medium expansion lower fusing porcelains and indirect restorative composites. Particularly, OPC Low Wear, K982377, Jeneric/Pentron, which is a low temperature ceramic.
Gold Core 55 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, single crowns, brugos, imposites, implant superstructures, substrate for medium expansion lower fusing porcelains me menter resear porcelain. The chemical composition of Gold Core 55 is as follows: Au - 55% Ag - 29% Pd - 10% Balance Amounts of: In, Sn, Zn, Ir
The provided document is a 510(k) summary for a dental alloy named "Gold Core 55." It describes the device's composition and intended use, and states that it is substantially equivalent to a previously cleared device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to a study proving the device meets acceptance criteria.
The document is purely administrative, confirming the FDA's review and clearance for marketing based on substantial equivalence to a predicate device. It does not include any performance data or study results.
Therefore, I cannot provide the requested information from the given 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.