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K Number
K191980
Device Name
CLEARFIL MAJESTY ES Flow
Manufacturer
Kuraray Noritake Dental Inc.
Date Cleared
2019-11-18

(117 days)

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

CLEARFIL MAJESTY ES Flow is indicated for the following restorative applications:

  • [1] Direct restorations for all cavity classes, cervical lesions (e.g. root surface caries, v-shape defects), tooth wear, and tooth erosion
  • [2] Cavity base / liner
  • [3] Correction of tooth position and tooth shape (e.g. diastema closure, tooth malformation)
  • [4] Intraoral repair of fractured restorations
  • [5] Cementation of ceramic and composite inlays, onlays and veneers with less than 2mm thickness
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental restorative material called CLEARFIL MAJESTY ES Flow. It details the device's indications for use and regulatory classification. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot provide the requested information based on the given input text. The information typically found in a 510(k) clearance letter focuses on regulatory approval based on substantial equivalence to predicate devices, rather than detailed performance study results and acceptance criteria. Such detailed study information would usually be found in the 510(k) submission itself or in published studies related to the 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.