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K Number
K120768
Device Name
ES FLOW
Manufacturer
SPIDENT CO., LTD.
Date Cleared
2012-05-03

(50 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
K051808
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

EsFlow is a low viscous, light cured hybrid composite dental tooth shade resin material. It is intended for use in various dental procedures, including direct anterior and posterior restorations (particularly for small/shallow/tunnel shaped cavities), as the first layer of direct restorations, blocking out cavity undercuts before fabricating indirect restorations, and repair of porcelain/composite materials.

Device Description

EsFlow is light-cured flowable composite resin which makes it ideal for small cavities in anterior and posterior teeth. It has the characteristics of good flowability, high compressive strength, and radiopaque. It has 17 shades: A1, A2, A3, A3.5, B2, B3, I, UO, LA1,LA2,LA3, LA3.5, LB2, LB3,LUO, White, Yellow.

AI/ML Overview

The provided text is a 510(k) summary for a dental resin material, EsFlow, and does not contain information about acceptance criteria for a device, nor does it describe a study proving a device meets such criteria in terms of performance metrics like sensitivity, specificity, or any clinical outcomes.

Instead, the document focuses on demonstrating that EsFlow is substantially equivalent to a predicate device (ESTELITE FLOW QUICK, K051808) based on:

  • Intended use
  • Material and chemical composition
  • Design and use concept
  • Mechanical properties (compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage, thermal expansion coefficient)
  • Biocompatibility and other safety tests in compliance with US regulations and ISO 4049.

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample sizes, ground truth, expert opinions, or MRMC studies, as these types of studies are not detailed in this 510(k) summary for a dental material. The document is about demonstrating substantial equivalence for regulatory clearance, not about clinical performance data in the way you've outlined.

§ 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.