N-HYBRIDE-COMPOSITE LC

• K Number: K113563
• Device Name: N-HYBRIDE-COMPOSITE LC
• Manufacturer: VOCO GMBH
• Date Cleared: 2011-12-21 ( 30 days)
• Product Code: EBF
• Regulation Number: 872.3690
• Type: Special
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a set of FDA letters and does not contain the information required to answer your request. The document is a 510(k) clearance letter for a dental resin material, and it primarily focuses on regulatory approval rather than a detailed study description with acceptance criteria and performance metrics.

Therefore, I cannot extract the information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from this document.

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.