(69 days)
Dental casting alloy for making restoration.
High gold casting alloy
The provided document is a 510(k) summary for a dental casting alloy, AURECAST 74. It describes the device, its intended use, and a comparison to a legally marketed predicate device (Jelenko Modulay). This document does not describe a study involving an AI/ML device or its acceptance criteria, performance, or validation methods.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, or MRMC studies for an AI/ML device from this text. The provided text is purely a regulatory submission for a traditional medical device (dental alloy).
§ 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.