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K Number
K040144
Device Name
QUIXX POSTERIOR RESTORATIVE
Manufacturer
DENTSPLY INTERNATIONAL
Date Cleared
2004-04-01

(70 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
K973235,K973221
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

QUIXX™ POSTERIOR RESTORATIVE is indicated for posterior Class I and II cavities.

Device Description

QUIXX™ POSTERIOR RESTORATIVE is a hybrid resincomposite restorative material for use in filling posterior dental cavities. The restorative consists of a single paste that is visible light cured.

AI/ML Overview

This document is a 510(k) premarket notification for a dental restorative material, not a study evaluating an AI-powered medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study design, expert involvement, and AI performance.

The document describes a conventional dental product, "QUIXX™ POSTERIOR RESTORATIVE," and its technological characteristics and intended use, comparing it to predicate devices. It discusses biocompatibility testing (cytotoxicity and mutagenicity) but does not involve any AI components or a study comparing its performance against specific acceptance criteria in the manner requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, or AI-related study findings from the provided text.

§ 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.