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K Number
K062382
Device Name
CLEARFIL DC BOND
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2006-09-27

(43 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K043177,K042913,K012440,K012432
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. Core build-ups using light-, dual-, or self-cure composite resin
  2. Direct restorations using light-cure composite resin
  3. Direct restorations using self-cure composite resin
  4. Cavity sealing as a pretreatment for indirect restorations
  5. Treatment of exposed root surfaces
  6. Intraoral repairs of fractured crowns/bridges made of porcelain, ceramics, hybrid ceramics or composite resin
Device Description

CLEARFIL DC BOND is a dual-cure (light- and /or self-cure), two-component, one-step bonding system that allows simultaneous treatment of both dentin and enamel. It is classified into Resin tooth bonding agent, 21 CFR Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to promote adhesion of restorative material to dentin, enamel, and metal.

AI/ML Overview

The provided text describes a dental bonding agent, CLEARFIL DC BOND, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study with detailed performance metrics in the way that would typically be described for a diagnostic AI device.

Therefore, I cannot populate the table and answer your questions as specified. The document primarily focuses on establishing substantial equivalence based on chemical ingredients and general effectiveness/performance claims (tensile bond strength and marginal sealing), rather than a detailed clinical or standalone performance study with specific acceptance criteria and ground truth.

Here's a breakdown of why the requested information cannot be provided from the given text:

  • Acceptance Criteria & Device Performance: The document states that "Tensile bond strength and marginal sealing characteristic (microleakage) tests performed on the applicant device have demonstrated that the applicant device is more effective and performs better than the predicate devices." However, it does not provide specific numerical acceptance criteria (e.g., "tensile strength must be > X MPa") or the reported numerical device performance results for either the applicant or predicate devices.
  • Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These are all details typically found in the methodology section of a detailed study, particularly for AI or diagnostic devices. This document is a 510(k) summary for a dental material, which focuses on chemical composition and general performance comparisons to establish substantial equivalence. These types of details are not usually included in such a submission.

§ 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.