(63 days)
Non-Precious Dental Casting Alloy. Suitable for use in the fabrication of Ceramic Fused to Metal (metallo-ceramic) dental restorations.
Not Found
The provided text describes a 510(k) premarket notification for a dental alloy, Ceracast-V. It does not contain information about acceptance criteria, device performance details, or any study involving AI assistance for medical image analysis. Therefore, I cannot generate the requested information based on the provided input.
The document is a clearance letter from the FDA, stating that Ceracast-V is substantially equivalent to legally marketed predicate devices for use as a non-precious dental casting alloy in ceramic fused to metal dental restorations. It does not involve any algorithm performance or clinical study data as typically seen with AI/ML-enabled medical devices.
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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.