(40 days)
Indications for Use: D-Sign V is to be used with conventional feldpathic porcelains. Also recommended for posts, attachments, short and long span bridges, and PFM crowns.
Not Found
This document is a 510(k) clearance letter from the FDA for the D-Sign V device. It does not contain information about acceptance criteria or a study proving device performance.
The letter confirms that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. It grants permission to market the device, subject to general controls provisions of the Act.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory clearance and substantial equivalence, not on specific performance study details or acceptance criteria.
§ 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.