(71 days)
VERA PDN, a cobalt-chromium based alloy in nugget form, is intended for use in the fabrication of custom-made removable denture appliances.
VERA PDN, a cobalt-chromium based alloy in nugget form
The provided text is a 510(k) premarket notification letter from the FDA regarding a dental alloy named Vera PDN. This document primarily concerns the regulatory approval for marketing the device based on its substantial equivalence to previously marketed devices. It does not contain information about specific acceptance criteria or the details of a study proving the device meets such criteria.
Therefore, I cannot provide the requested information. The document is a regulatory approval letter, not a study report.
§ 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.