(61 days)
Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses:
precious metal inlays, onlays, and crowns;
precious metal bridges, bars, and attachments;
precious metal copings and bridges for porcelain-fusedto-metal restorations.
Orion WX is recommended for use with any normal-fusingtemperature porcelain product in porcelain-fused-to-metal restorations of from one crown up to a full-span bridge.
After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
Orion WX Dental Alloy
This document is a 510(k) premarket notification letter from the FDA regarding the Orion WX Dental Alloy. It confirms the device's substantial equivalence to legally marketed predicate devices.
The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically found for complex medical devices or AI algorithms. This is an approval letter for a dental alloy, which primarily relies on material properties and established clinical use, rather than performance metrics from a diagnostic study.
Therefore, I cannot provide the requested information in the table format or answer the questions related to studies, sample sizes, ground truth, or MRMC studies, as this type of information is not present in the provided text for this specific device.
§ 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.