(60 days)
Supremcast Alloy is a Dental Ceramic Casting Alloy. For use in dental laboratories. Suitable for use in fabrication of ceramic fused to metal Dental restoration.
Supremcast Alloy is a Dental Ceramic Casting Alloy.
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy named "Supremcast." It confirms the device's substantial equivalence to legally marketed predicate devices and allows it to be marketed.
However, the letter does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot extract the requested information to fill out the table and answer the specific questions about a device study.
The document is purely a regulatory approval letter and does not include the technical study details that would typically be found in a clinical trial report or a scientific publication.
§ 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.