4 ALL (DW286A)

• K Number: K020253
• Device Name: 4 ALL (DW286A)
• Manufacturer: IVOCLAR VIVADENT, INC.
• Date Cleared: 2002-04-17 ( 83 days)
• Product Code: EJH
• Regulation Number: 872.3710
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

4 ALL (DW286 A) alloy intended to be used for onlay, ¾ crows, 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, "4 ALL (DW286 A)". This document does not contain any information about acceptance criteria or a study that proves a device meets those criteria.

The letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• Outlines general regulatory requirements for marketing the device.
• States the intended indications for use of the device.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, training set details) because it is not present in the provided text.

Regulation Number and Section

§ 872.3710 Base metal alloy.

(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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.