K Number
K113444
Manufacturer
Date Cleared
2011-12-21

(30 days)

Product Code
Regulation Number
872.3690
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • filling minimally invasive cavities of all classes
  • filling small class I cavities and extended fissure sealing
  • filling class II-V cavities including V-shaped defects and cervical caries -
  • blocking out undercuts -
  • lining or coating cavities
  • repairing fillings and veneers .
  • luting translucent prosthetic pieces (e.g. full ceramic crowns, etc.) -
Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a dental material (N-Hybrid-Composite LC Flow). It does not contain information about acceptance criteria, study details, or performance data in the context of an AI/ML device. Therefore, I cannot extract the requested information.

The document primarily focuses on:

  • Confirming that the device is substantially equivalent to a predicate device.
  • Listing the indications for use of the dental composite material.
  • Emphasizing compliance with FDA regulations for medical devices.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) submission document that details the performance testing of an AI/ML device.

§ 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.