(91 days)
This device is a "white" colored, casting alloy for use in the construction of dental inlay and onlay 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 "white" colored, casting alloy for use in the construction of dental inlay and onlay prosthetic devices.
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy device (Platalloy). It states that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain information about:
- Acceptance criteria and reported device performance in a table.
- Details about any study conducted to prove the device meets acceptance criteria.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or training set information.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input.
§ 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.