(77 days)
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
Palladium silver based casting alloy
Here's an analysis of the provided text regarding the Palceram 56 dental casting alloy, addressing your request for acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary for a medical device seeking market clearance in the US. For such devices, often the "study" proving acceptance criteria is a comparison to a legally marketed predicate device demonstrating substantial equivalence, rather than a standalone clinical trial in the way a pharmaceutical might have. This document primarily focuses on demonstrating that the new device is as safe and effective as an existing one through comparison of material properties.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" here are implicitly linked to the properties of the legally marketed predicate device, "Aurium Aurolite IK." The new device, "Palceram 56," is considered acceptable if its properties are comparable or within acceptable ranges relative to the predicate. The document doesn't explicitly state numerical acceptance thresholds for each property, but rather presents a side-by-side comparison to demonstrate similarity.
| Property/Test | Acceptance Criteria (Implicitly from Aurium Aurolite IK) | Reported Palceram 56 Performance | Outcome (Comparison) |
|---|---|---|---|
| Composition (weight%) | |||
| Ag | ~30% | 32% | Similar |
| Pd | ~58% | 56.5% | Similar |
| Sn | ~6% | 3.9% | Reasonably similar (minor difference) |
| In | ~4% | 7.3% | Reasonably similar (minor difference) |
| 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.