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K Number
K120767
Device Name
ES BOND
Manufacturer
SPIDENT CO., LTD.
Date Cleared
2012-05-24

(71 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K945604
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. All Direct Composite Restorations
  2. Directed Shrinkage Composite Restorations
  3. Desensitization of Crown Preparations Prior to Impression Making/Provisionalization
  4. Composite Core Build-Ups
  5. Composite to Composite (Repair)
  6. Composite to Metal/Set Amalgam (Direct Veneering)
  7. Root Desensitization
Device Description

EsBond is 5th generation that provides high bonding strengths in a convenient single bottle application. That single component bonding agent designed to bond all classes of direct composite restorations to dentin, enamel, as well as composite, treated porcelain and set amalgam.

AI/ML Overview

The provided text is a 510(k) summary for a dental bonding adhesive (EsBond) and its FDA clearance letter. It does not contain information about acceptance criteria, a specific study proving it meets these criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document states that EsBond has "similar mechanical properties as the predicate device; compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience" and that "Safety tests including biocompatibility have been performed to ensure the devices comply with the US regulations and ISO 4049." However, it does not provide the specific acceptance criteria for these properties or the results of the tests against these criteria.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample sizes used for the test set and the data provenance.
  3. Number of experts used to establish the ground truth for the test set and their qualifications.
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study details.
  6. Standalone performance details.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How the ground truth for the training set was established.

This document focuses on establishing substantial equivalence to a predicate device (ECLIPTOMER, BISCO, INC., K945604) based on intended use, materials, chemical composition, design, use concept, and general mechanical properties, rather than providing a detailed study report with specific acceptance criteria and performance data as you've requested for an AI/device study.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.