(129 days)
Jelfine-52 ( RD-0901 ) is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain application ( PFM-alloy ) and compatible with most of the porcelain in the market. Jelfine-52 exhibits similar physical and thermal properties like Jelenko's "Olympia" and it provides quality restorations with rich platinum color. It polishes to a high luster. This high noble alloy is copper and silver free. Jelfine-52 provides accurate margins and it is perfect for single, 3 to 4 crowns and long span bridges.
Jelfine-52 ( RD-0901 ) is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain application ( PFM-alloy ) and compatible with most of the porcelain in the market. Jelfine-52 exhibits similar physical and thermal properties like Jelenko's "Olympia" and it provides quality restorations with rich platinum color. It polishes to a high luster. This high noble alloy is copper and silver free. Jelfine-52 provides accurate margins and it is perfect for single, 3 to 4 crowns and long span bridges.
The provided text is a 510(k) premarket notification FDA letter from 1998 for a dental alloy named JELFINE-52. This type of document is a regulatory approval for a medical device and does not contain information about a clinical study with acceptance criteria and device performance as typically understood for software AI/ML devices.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the manufacturer demonstrated that their new device is as safe and effective as another legally marketed device, and therefore does not require new efficacy studies.
Therefore, I cannot fulfill your request for information on acceptance criteria and a study that proves the device meets those criteria, as this information is not present in the provided document. The questions you've asked are typically relevant for AI/ML medical devices undergoing de novo or PMA pathways, or 510(k)s that include detailed performance studies, which is not the case here.
§ 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.