(37 days)
This is a yellow ceramic alloy for single units, implants prosthetics, single & 3/4 crowns, and short span bridges.
CERANUM 90 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, single crowns, bridge, implant superstructures and substrate for medium expansion with lower fusing porcelains and indirect restorative composites. CERANUM 90 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength. durability and color of gold.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the CERANUM 90 device, structured to answer your specific questions.
In this 510(k) summary, the device is a dental casting alloy, and the "study" is a comparison to a legally marketed predicate device, not a typical diagnostic or AI-based study. As such, some of your requested categories (like MRMC studies, training set, or expert adjudication for image ground truth) are not applicable.
Acceptance Criteria and Device Performance for CERANUM 90
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Predicate: Jel Bios 90) | Reported Device Performance (Ceranum 90) |
|---|---|---|
| Composition (Weight %) | ||
| Au | 90.00 | 90.00 |
| Pt | 7.40 | 4.00 |
| Pd | - | 11.95 |
| Ag | 1.0 | 0.05 |
| Cu | - | 0.2 |
| Sn | - | 0.40 |
| Fe |
§ 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.