(41 days)
CERANUM 82 is intended for manufacturing:
- Single Crown -
- Bridges -
- Implant superstructures
CERANUM 82 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for single crowns, bridge, implant superstructures and substrate for medium expansion with lower fusing porcelains and indirect restorative composites. CERANUM 82 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength, durability and color of gold.
The provided text describes a 510(k) premarket notification for a dental casting alloy, Ceranum 82, and its substantial equivalence to a predicate device, Metalor's V-Supragold. This is a material comparison, not a medical device involving AI, image analysis, or clinical performance studies in the way the request implies. Therefore, many of the requested fields are not applicable.
Here's the relevant information extracted and presented:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the properties of the predicate device, Metalor's V-Supragold, and relevant industry standards (ANSI/ADA 5 and ISO 9693). The device (Ceranum 82) meets these criteria by demonstrating comparable physical and mechanical properties within acceptable ranges. The "acceptance" is based on showing substantial equivalence rather than meeting strict predefined thresholds for a new clinical outcome.
| Acceptance Criteria (Predicate Device - V-Supragold) | Reported Device Performance (Ceranum 82) |
|---|---|
| Composition (Weight %) | |
| Au: 83.00% | Au: 82.00% |
| Pt: 8.8% | Pt: 8.87% |
| Pd: 5.20% | Pd: 3.8% |
| In: 2.8% | In: 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.