(41 days)
Prospector Plus is a noble alloy under the Identalloy and ADA classification system for Dental Alloy. It is designed for Type-III hard Crown and Bridge alloy. Prospector Plus provides quality restorations. It is low gold containing alloy vet having rich brilliant gold color and it polishes to a higher luster. This noble alloy, free from Copper, makes it excellent tarnish resistant. Prospector Plus provides extremely accurate margins. It is perfect for Single Crown, Veneer Crowns, 3 to 4 crowns and short span bridges.
Prospector Plus is a noble alloy under the Identalloy and ADA classification system for Dental Alloy. It is designed for Type-III hard Crown and Bridge alloy. Prospector Plus provides quality restorations. It is low gold containing alloy vet having rich brilliant gold color and it polishes to a higher luster. This noble alloy, free from Copper, makes it excellent tarnish resistant. Prospector Plus provides extremely accurate margins.
The provided document is a 510(k) premarket notification letter from the FDA to J.F. Jelenko & Company, Incorporated, regarding a dental alloy named "Prospector Plus." This document confirms the device's substantial equivalence to a predicate device but does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The letter is a regulatory approval, and while it indicates the device's intended use and classification, it does not delve into the specific performance metrics or clinical study results that would typically be detailed in a submission proving performance against acceptance criteria.
Therefore, I cannot provide answers to the requested information based on the given 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.