(90 days)
CONCORD 88 (PM-43) is a yellow colored gold/platinum dental casting alloy for restorations subject to high stress and that require porcelain enamels be fused to some of the surfaces. It may also be used as a Type III (hard) crown and bridge alloy. It is intended for use in the manufacture of single units, ¾ crowns, and short-span bridgework.
CONCORD 88 (PM-43) is a yellow colored gold/platinum dental casting alloy.
The provided text is a 510(k) premarket notification letter from the FDA for a dental casting alloy named "Concord 88." This document is not a study report for an AI/ML powered medical device, but rather a regulatory approval for a material.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set information cannot be extracted from this document, as it pertains to a different type of medical device approval.
§ 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.