(37 days)
Porcelain - to - metal restorations
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a dental device called "XeraFit." This document does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria.
The letter is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses:
- Device Name: XeraFit
- Regulation Number and Name: 872.3710, Base Metal Alloy
- Product Code: EJH
- Intended Use: Porcelain-to-metal restorations
- Regulatory Class: II
The document focuses on the administrative aspects of FDA clearance, such as substantial equivalence, regulatory compliance, and contact information for further inquiries. It does not include technical specifications, performance metrics, study designs, or results from any performance testing.
Therefore, I cannot provide the requested information from this document.
§ 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.