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BegoStar is a precious dental casting alloy to make metal fused to ceramic dental restorations
Pontorex G is a precious dental casting alloy to make crown and bridge dental restorations
Platinlloyd KF is a precious dental casting alloy to make metal fused to ceramic dental restorations
Bio Platinilloyd is a precious dental casung alloy to make metal fused to ceramic dental restorations
Begopal S is a precious dental casting alloy to make metal fused to ceramic dental restorations
Begorex 45 is a precious dental casting alloy to make metal fused to ccramic dental restorations
PontoStar Ti is a precious dental casting alloy to make metal fused to ceramic dental restorations
Pontolloyd G is a precious dental casting alloy to make metal fused to ceramic dental restorations
Bio Pontostar XL is a precious dental casting alloy to make metal fused to ceramic dental restorations
Begolloyd 60 is a precious dental casting alloy to make crown and bridge dental restorations
Begolloyd PF is a precious dental casting alloy to make crown and bridge dental restorations
PontoStar G is a precious dental casting alloy to make metal fused to ceramic dental restorations
Gold EWL H is a precious dental casting alloy to make crown and bridge dental restorations
Platinlloyd M is a precious dental casting alloy to make crown and bridge dental restorations
Begopal 300 is a precious dental casting alloy to make metal fused to ceramic dental restorations
Begostar LFC is a precious dental casting alloy to make metal fused to ceramic dental restorations
Gold Dental Casting Alloys
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document appears to be a series of FDA 510(k) forms for various dental casting alloys, primarily indicating their names and intended uses. It confirms that these devices have been found substantially equivalent to predicate devices. There is no mention of any clinical trials, performance metrics, or study designs in 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.