V-SUPRAGOLD, ALLOY NO. 5024

• K Number: K993507
• Device Name: V-SUPRAGOLD, ALLOY NO. 5024
• Manufacturer: METALOR DENTAL USA CORP.
• Date Cleared: 1999-12-06 ( 52 days)
• Product Code: EJT
• Regulation Number: 872.3060
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Fabrication of Porcelain-Fused-to-Metal Dental Crowns and Bridges.

Device Description

Not Found

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy named "V-Supragold." It confirms substantial equivalence and allows the marketing of the device.

This document does not contain information about:

• Acceptance criteria and reported device performance in a numerical table.
• Details of a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set specifics).

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Regulation Number and Section

§ 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.