(77 days)
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
Low gold palladium based casting alloy
- Acceptance Criteria and Reported Device Performance:
| Property | Acceptance Criteria (Predicate Device: Legacy XT) | Reported Device Performance (Palaurex 76KF) |
|---|---|---|
| Melting point range (solid.) | 1190 °C | 1115 °C |
| Melting point range (liquid) | 1300 °C | 1285 °C |
| Hardness (Vickers 5/30) - soft | 245 | 220 |
| Hardness (Vickers 5/30) - hard | (Not specified for predicate) | 260 |
| Yield strength (MPa) - soft | 552 | 630 |
| Yield strength (MPa) - hard | (Not specified for predicate) | 865 |
| Elongation (%) - soft | 30 | 18 |
| Elongation (%) - hard | (Not specified for predicate) | 4 |
| CTE (x10-6/°C) | 14.3 | 14.1 |
| Density (g/cm3) | 10.8 | 10.6 |
| Composition (weight%) | ||
| Au | 2 | 2 |
| Ag | 10 | 7.5 |
| Pd | 75.4 | 75.6 |
| Sn | 0 | 2.9 |
| In | 6 | 6.2 |
| Ga | 6 | 5.5 |
| 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.