(85 days)
- Identification: A base metal alloy is a device composed of a material such as a mixture of Nickel and Chromium
- Intended Use: This material is to be used by the dentist in the fabrication of a custom-made dental device, such as a porcelain veneer for a tooth.
- Classification: Class II
Hi Bond Non-Precious Ceramic Alloy is a base metal alloy composed of a material such as a mixture of Nickel and Chromium.
The provided text is a 510(k) clearance letter from the FDA for a dental alloy, specifically "Hi Bond Non-Precious Ceramic Alloy." This document does not contain any information about acceptance criteria, device performance studies, or clinical trial data.
The letter is a regulatory document confirming that the device is "substantially equivalent" to devices already on the market, which is a different concept than providing evidence of performance through a study described in the prompt's request.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence, not on specific performance metrics or studies as outlined in your prompt.
§ 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.