(69 days)
Dental casting alloy for making restoration.
High gold casting alloy
This document describes the AURECAST 83 Dental casting alloy and its substantial equivalence to a legally marketed predicate device, Jelenko Benchmark I. The acceptance criteria and the study that proves the device meets them are based on comparisons of composition and physical/mechanical properties, not on a clinical effectiveness study with human readers or outcomes data.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, "acceptance criteria" are implicitly defined by the parameters deemed important for substantial equivalence to the predicate device. The "reported device performance" is the measured performance of AURECAST 83.
| Characteristic | Acceptance Criteria (Predicate: Jelenko Benchmark I) | Reported Device Performance (Aurecast 83) |
|---|---|---|
| Composition (weight%) | ||
| Au | 83 | 83.1 |
| Ag | 8 | 6.7 |
| Pt | 1 | 0 |
| Cu | 5.2 | 8.7 |
| Zn | 0 | 1.5 |
| In | 2.2 | 0 |
| Ir |
§ 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.