ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)

• K Number: K982201
• Device Name: ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)
• Manufacturer: FOREMOST DENTAL MFG., INC.
• Date Cleared: 1998-08-10 ( 49 days)
• Product Code: EBF
• Regulation Number: 872.3690
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Core material- when a tooth is fractured a Technique called Post and core is used to restore functum. A post is cemented into the endo dentically Treated tooth. A core material is used to build up around the tooth and post so that a finished appliance can be placed.

Device Description

Not Found

AI/ML Overview

This appears to be a 510(k) clearance letter from the FDA for a dental core material, not a document describing a study for an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not present in this document.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, and does not involve performance studies against acceptance criteria in the way an AI/ML device would.

Therefore, I cannot provide the requested table and study details.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.