(39 days)
Chroloy Solder is intended to be used by dentists and dental laboratories for the as a solder for Chroloy Partial Denture alloy. It is used in the fabrication of removable partial dentures.
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I am sorry, but based on the provided document, I cannot answer the question. The document is a 510(k) clearance letter for a dental solder ("Chroloy Solder") and primarily focuses on its substantial equivalence to predicate devices and regulatory compliance. It does not provide information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment as would be relevant for a medical device with diagnostic or AI components.
§ 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.