(20 days)
Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal inlays, onlays, and crowns; precious metal bridges, bars, posts, and attachments; precious metal copings and bridges for porcelain-fused-to-metal restorations. When used for porcelain-fused-to-metal restorations it is intended by the manufacturer that only Carrara Porcelain products be used with the Carrara alloys. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
Not Found
This FDA 510(k) clearance letter (K980597) for "Carrara Dental Alloys" focuses on substantial equivalence to predicate devices and does not contain information on acceptance criteria or a study proving the device meets specific performance criteria. Therefore, I cannot provide the requested information based on the given document.
The document primarily states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. It covers regulatory aspects like general controls, classification, and labeling.
To answer your request, a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a comprehensive test report, would be needed.
§ 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.