(56 days)
Maintbonc. A is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain, application and compatible with low fusing porcelains in the market. Mainbond A is a rich yellow color, palladium free alloy and it provides quality restoration. It can also be used as Type-IV crown and bridge alloy. It polishes to a high luster and can be used for Single, 3 to 4 crowns.
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This document is a 510(k) premarket notification approval letter for a dental alloy named "Mainbond A". It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information from the provided 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.