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K Number
K132141
Device Name
BEAUTIFIL BULK FLOWABLE
Manufacturer
SHOFU DENTAL CORPORATION
Date Cleared
2013-10-03

(84 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • . Base in Class I and II direct restorations
  • . Liner under direct restorative materials
  • . Restorations of small posterior cavities (including occlusal restorations)
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a dental resin material (Beautifil Bulk Flowable). This document outlines the FDA's marketing clearance for the device based on its substantial equivalence to a predicate device.

This document does NOT contain information about acceptance criteria, detailed device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.

Therefore, I cannot extract the information necessary to fulfill your request. The document discusses regulatory aspects, product classification, and indications for use, but not the specific technical study details you are looking for.

§ 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.