D.SIGN 53, MODEL NA1012204 by IVOCLAR VIVADENT, INC. | FDA 510(k) Summary

FDA 510(k) Search

K Number

Device Name

D.SIGN 53, MODEL NA1012204

Manufacturer

IVOCLAR VIVADENT, INC.

Date Cleared

2002-01-30

(50 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

d.SIGN 53 alloy intended to be used for onlays, % crowns, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental alloy, d.SIGN 53. It does not contain any information about acceptance criteria, study details, device performance metrics, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot fulfill your request for the specific information regarding a study and its results from the given text.

Summary

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.