(32 days)
Indications for Use: D-Sign III is to be used with conventional feldpathic porcelains. Also recommended for 3/4 crowns, telescop crowns, conus crowns, posts, attachments, short and long span bridges, PFM crowns.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental device called "D-Sign III". It establishes substantial equivalence to a legally marketed predicate device but does not contain any information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The letter only confirms that the device can be marketed based on its equivalence to existing products.
§ 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.