(64 days)
d.SIGN 15 (DW286 B) alloy intended to be used for onlay, ¾ crows, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns.
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This document is a 510(k) premarket notification letter from the FDA regarding a dental alloy, d.SIGN 15. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. However, this type of document, a 510(k) clearance letter, does not contain the detailed study information (acceptance criteria, performance data, sample sizes, expert qualifications, etc.) that you are asking for.
The 510(k) notification process primarily focuses on demonstrating substantial equivalence to a predicate device, often relying on existing data and widely accepted standards for similar devices. It does not typically involve new clinical studies or detailed performance trials as would be expected for a novel device or a PMA application.
Therefore, based on the provided text, I cannot extract the information you requested about acceptance criteria, study details, sample sizes, expert information, or ground truth establishment. This document only confirms the regulatory clearance for marketing the device.
§ 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.