KATANA AVENCIA Block

• K Number: K153476
• Device Name: KATANA AVENCIA Block
• Manufacturer: Kuraray Noritake Dental, Inc.
• Date Cleared: 2016-08-23 ( 265 days)
• Product Code: EBF
• Regulation Number: 872.3690
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Fabrication of inlays, onlays, veneers and full contour crown restorations, using a dental CAD/CAM system.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a dental material (KATANA AVENCIA Block) and does not contain information about the acceptance criteria or study details for an AI/ML-enabled medical device performance evaluation.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance
2. Sample size and data provenance for the test set
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This document is solely a regulatory clearance for a physical dental block and does not involve AI/ML software.

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.