V-GNATHOS SUPRA

• K Number: K013769
• Device Name: V-GNATHOS SUPRA
• Manufacturer: METALOR TECHNOLOGIES USA
• Date Cleared: 2002-01-22 ( 70 days)
• Product Code: EJT
• Regulation Number: 872.3060
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Substructures for porcelain-to-metal crowns and bridges. Suprastructures on implants, milling works."""

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Metalor Technologies USA Dental Division regarding their device, V-Gnathos Supra. This document primarily focuses on the regulatory approval process and does not contain information about acceptance criteria or a study that proves the device meets those criteria.

Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval letter, not a study report.

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.