(43 days)
It is a gold / platinum porcelain-to-metal alloy with high strength and hardness with superfine grain structure. It is suitable for longspans and bridges. It is a high noble alloy and the high goldcontent makes it compatible with most porcelains in the market.Jelbond-PdF blend well with tissue and enhances the esthetic qualities of the finished restoration.
It is a gold / platinum porcelain-to-metal alloy with high strength and hardness with superfine grain structure.
This document is a 510(k) premarket notification approval letter for the device "Jelbond-PdF". It does not contain any information regarding acceptance criteria, device performance, or study details such as sample sizes, ground truth establishment, or expert qualifications.
The letter confirms that the FDA has reviewed the submission and found the device to be substantially equivalent to a legally marketed predicate device. This substantial equivalence determination allows the manufacturer to market the device.
Therefore, I cannot provide the requested information based on the input text.
§ 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.