(77 days)
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
Low gold palladium based casting alloy
The provided text describes a 510(k) summary for a dental casting alloy named PALAUREX 78, seeking to establish its substantial equivalence to a legally marketed device, Jelenko Freedom Plus. It is not a study proving a device meets acceptance criteria in the typical sense of a clinical or performance study with defined performance metrics like sensitivity, specificity, or reader improvement. This document is a pre-market notification to the FDA, demonstrating that a new device is as safe and effective as a predicate device.
Therefore, the requested information elements such as "sample size for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," and "standalone performance" are not applicable to this type of submission. This submission focuses on comparing the new device's technological characteristics (composition and physical/mechanical properties) to a legally marketed predicate device.
Here's the information that can be extracted from your input, framed within the context of substantial equivalence rather than traditional acceptance criteria:
1. Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this 510(k) submission are not explicit numerical thresholds for clinical performance (like accuracy metrics). Instead, the acceptance criterion is demonstrating substantial equivalence to the predicate device, Jelenko Freedom Plus, by showing similar technological characteristics and an expectation of similar biological effect and intended use. The "reported device performance" is a comparison of these characteristics.
| Characteristic | Acceptance Criterion (Predicate Device: Jelenko Freedom Plus) | Reported Performance (New Device: PALAUREX 78) |
|---|---|---|
| Composition (weight%) | ||
| % Au | 2 | 2 |
| % Pd | 78.4 | 77.8 |
| % Cu | 8 | 13 |
| % In | 6 | - |
| % Ga | 5 | 7 |
| % Ru |
§ 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.