(95 days)
The indicated usage for this product is as a ceramic alloy for use in the construction of ceramic single unit crowns Fixed Restorations.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a dental ceramic alloy. It does not contain information regarding acceptance criteria for a device's performance, nor does it describe a study that proves the device meets such criteria.
The document states that the device, "BIO-97," is a "ceramic alloy for use in the construction of ceramic single unit crowns Fixed Restorations." However, it does not provide any performance metrics, study designs, sample sizes, or ground truth details.
Therefore, I cannot fulfill the request for information about acceptance criteria or a study proving device performance based on the input provided. The document is largely administrative, confirming the device's substantial equivalence to previously marketed devices and outlining regulatory obligations.
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are 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.