V-DELTA 450

• K Number: K972683
• Device Name: V-DELTA 450
• Manufacturer: METALOR DENTAL USA CORP.
• Date Cleared: 1997-08-18 ( 32 days)
• Product Code: EJS
• Regulation Number: 872.3060
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

For use in the Fabrication of Porcelain-Fused-to-Metal Dental Crowns and Bridges.

Device Description

Not Found

AI/ML Overview

The provided documents are a 510(k) premarket notification letter from the FDA regarding a dental device called "V-Delta 450" and its indications for use. This type of document does not contain information about acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot provide the requested information. The documents primarily confirm the substantial equivalence of the device to a predicate device and approve its marketing, outlining regulatory compliance requirements.

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.