SHOFU BLOCK HC

• K Number: K130841
• Device Name: SHOFU BLOCK HC
• Manufacturer: SHOFU DENTAL CORPORATION
• Date Cleared: 2013-09-11 ( 169 days)
• Product Code: EBF , EBG
• Regulation Number: 872.3690
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

For fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental labs and manufacturers using a dental CAD/CAM system.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification from the FDA regarding the "SHOFU BLOCK HC" device, which is a tooth shade resin material for dental restorations. This document is a regulatory approval, not a scientific study report.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not available in the provided text.

The document primarily focuses on the regulatory determination of substantial equivalence to a predicate device, allowing the device to be marketed. It does not contain the detailed technical performance data or study methodology that would typically be found in a clinical or scientific study report.

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.