(48 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.
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.
This document is a 510(k) premarket notification letter from the FDA regarding a dental alloy, Verabond 2V. It confirms that the device is substantially equivalent to legally marketed predicate devices.
The information requested in the prompt, specifically related to acceptance criteria and a study proving the device meets those criteria, is not present in the provided document.
This letter is a regulatory approval notice based on substantial equivalence, not a detailed report of a clinical or performance study with specific acceptance criteria.
Therefore, I cannot provide the requested table and study details.
§ 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.