(37 days)
This is a yellow casting alloy for inlay / onlays, crowns, short span bridges, long span bridges, removable partials.
LUCIUS 76 is a platinum-free crown and bridge alloy. This device is dependable 76% gold alloy with a high gold appearance. LUCIUS 76 is an excellent for inlays, three-quarter crowns, long and short-span bridges.
The provided document is a 510(k) summary for a dental casting alloy, not an AI/ML medical device. Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device are not applicable or cannot be extracted from this particular document.
However, I can provide the information that is present in the document related to the device's characteristics and its comparison to a predicate device, which serves as its "acceptance criteria" and "study" for substantial equivalence.
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like a dental alloy, "acceptance criteria" for 510(k) clearance are primarily about demonstrating substantial equivalence to a legally marketed predicate device. This is typically done by comparing characteristics like composition and physical/mechanical properties. The "reported device performance" is the measured values for the new device and the predicate.
| Characteristic | Acceptance Criteria (Predicate: Argenco 77**) | Reported Device Performance (LUCIUS 76) |
|---|---|---|
| Composition (Weight %) | ||
| Au (%) | 76.0 | 76.0 |
| Pt (%) | 1.0 | 1.0 |
| Pd (%) | - (Not present) | 2.0 |
| Ag (%) | 13.0 | 11.3 |
| Cu (%) | 8.45 | 9.99 |
| Zn (%) |
§ 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.