LogoFDA 510(k) Search
K Number
K012440
Device Name
MODIFICATION TO CLEARFIL LINER BOND 2V
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2001-09-05

(36 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K974486
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

CLEAFIL LINER BOND 2V is indicated for the following applications:

  • Direct filling restorations using light-cure or chemical-cure composite resin 1)
    1. Bonded amalgam restorations
    1. Treatment of hypersensitive and/or exposed root surfaces
  • Cavity sealing as a pretreatment for indirect restorations 4)
    1. Intraoral repairs of facing crowns using light-cure composite resin
    1. Cementing laminate veneers, inlays and onlays made of porcelain (or composite resin) using composite resin cement
Device Description

CLEARFIL LINER BOND 2V is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. PROTECT LINER F is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of material such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth. CLEARFIL PORCELAIN BOND ACTIVATOR was permitted to market under its 510(k) notification submission.

AI/ML Overview

This document is a 510(k) summary for a dental material, CLEARFIL LINER BOND 2V. It primarily focuses on an administrative change regarding the manufacturer's name and address, stating that the device itself is essentially the same as a previously cleared predicate device (K974486).

Therefore, the information typically requested regarding acceptance criteria and a study proving a novel device meets those criteria is not present in this document. This submission is for an administrative change, not a new device.

Here's a breakdown of why the requested information cannot be provided from this document:

  1. A table of acceptance criteria and the reported device performance: This document does not present any specific performance data or acceptance criteria because it's a notification about an organizational change, not a new product with new performance claims. The device is being cleared based on its substantial equivalence to a predicate device, which implies its performance aligns with that predicate without requiring new testing for this specific submission.

  2. Sample size used for the test set and the data provenance: No test set is mentioned.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no new test set.

  4. Adjudication method for the test set: Not applicable.

  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is a dental material, not an AI-based diagnostic tool. Therefore, an MRMC study with AI assistance is not relevant or included.

  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a dental material.

  7. The type of ground truth used: Not applicable.

  8. The sample size for the training set: Not applicable, as this is a dental material, not an algorithm.

  9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The 510(k) summary explicitly states:

  • "The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes." (Section 3)
  • "This device is essentially the same as CLEARFIL LINER BOND 2V manufactured by Kuraray Co., Ltd. (K974486). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL LINER BOND 2V." (Section 6)

This means that the device is not undergoing new performance testing for this submission. Its "acceptance criteria" and "proof of meeting them" would have been established during the original 510(k) clearance (K974486) for the predicate device, which is not detailed here. The current submission relies on the established equivalence to that predicate.

§ 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.