(77 days)
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
Gold reduced palladium based casting alloy
The provided document is a 510(k) summary for a dental casting alloy, Hipallaur 19. It focuses on demonstrating substantial equivalence to a predicate device (Aurolite 2A) through a comparison of composition and physical/mechanical properties. This type of submission is not a clinical study report and therefore does not contain the information requested in your prompt regarding acceptance criteria, study design, expert ground truth, or human-AI performance.
The document discusses the technical characteristics of the device and its predicate, including:
- Comparison of composition (weight %):
- Legal (Aurolite 2A): Au (13.5), Ag (27.8), Pd (49.5), Sn (4.6), In (4.4), Fe (0), Mn (0), Ru (x
§ 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.