(37 days)
This device is a nonprecious, nickel-chromium-molybdenum based ceramic casting alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872. the classification name for this device is Base Metal Alloy, a Class II device.
nonprecious, nickel-chromium-molybdenum based ceramic casting alloy
The provided document is an FDA 510(k) clearance letter for a dental alloy named "VeraBond 2." This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a regulatory clearance letter rather than a technical study report.
Therefore, I cannot provide the requested information from this document. The letter simply states that the FDA has reviewed the device and determined it to be "substantially equivalent" to predicate devices already on the market, thus allowing it to be marketed. It refers to the "indications for use" as stated in an enclosure, but the enclosure itself (which would detail the device's properties and intended use) is not present in the provided text.
§ 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.