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510(k) Data Aggregation

    K Number
    K023842
    Device Name
    CLEARFIL SE BOND PLUS
    Manufacturer
    KURARAY MEDICAL INC.
    Date Cleared
    2003-02-11

    (85 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K012441,K021805,K855211,K012707,K012442,K012440,K993917,K953612,K982394,K014027
    Why did this record match?
    Reference Devices :

    K012441, K021805, K855211, K012707

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CLEARFIL SE BOND PLUS is indicated for the following applications:

    1. Direct restorations using light-cured composite resin or compomer
    2. Cavity sealing as a pretreatment for indirect restorations
    3. Treatment of hypersensitive and/or exposed root surfaces
    4. Intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics or composite resin using light cured composite resin
    5. Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin
    6. Core build-ups using light- or dual-cured composite resin
    7. Cavity sealing under amalgam restorations
    Device Description

    CLEARFIL SE BOND PLUS 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. This device consists of the primer, the bond and the accessories, and is substantially equivalent in design to CLEARFIL SE BOND.

    AI/ML Overview

    The provided text describes the submission of a 510(k) premarket notification for a dental adhesive system called "CLEARFIL SE BOND PLUS". The submission aims to establish substantial equivalence to predicate devices, rather than proving the device meets specific acceptance criteria in a study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a diagnostic AI device is not available in this document.

    However, I can extract information related to the device's properties and comparisons to predicate devices, which serve as a form of "acceptance criteria" in the context of a 510(k) submission for a non-AI device.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (based on equivalence to predicate devices)Reported Device Performance
    Safety (Biocompatibility): Substantially equivalent safety to legally marketed predicate devices.Biocompatibility of the new ingredient (MDPB) and the device as a whole were evaluated according to ISO 7405:1997 and ISO 10993-1:1997. The device was judged to be substantially equivalent in safety to the legally marketed predicate devices.
    Effectiveness (Mechanical Properties - Bond Strengths): Bond strengths between bovine tooth and composite resin/fresh amalgam, and between composite resin and various substances for intra-oral repairs, substantially equivalent to legally marketed predicate devices.The bond strengths between bovine tooth and a composite resin and a fresh amalgam were evaluated in comparison with legally marketed predicate devices (e.g., CLEARFIL SE BOND). Additionally, bond strengths between composite resin and various substances were evaluated for intraoral repairs of fractured crowns/bridges. The device was found to be substantially equivalent in effectiveness to the legally marketed predicate devices.
    Effectiveness (Marginal Sealing): Marginal sealing for direct filling and cavity sealing under amalgam restoration substantially equivalent to legally marketed predicate devices.Marginal sealing was evaluated when the device was used for direct filling and cavity sealing under amalgam restoration. The device was found to be substantially equivalent in effectiveness to the legally marketed predicate devices.
    Physical Properties (Fluoride Releasing): Amount of fluorine ion released and changes in mechanical strength due to fluorine releasing, substantially equivalent to legally marketed predicate devices.The amount of fluorine ion from the cured material immersed in water was evaluated in comparison with predicate devices (e.g., TOKUYAMA ONE-UP-BOND F, IMPERVA FLUORO BOND, PANAVIA F). Changes in mechanical strength due to fluorine releasing were also evaluated. The device was found to be substantially equivalent in the fluoride releasing property, including the change of mechanical strength, to the legally marketed predicate devices.

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not specify a "test set" in the context of an AI study. For the evaluated properties (biocompatibility, mechanical properties, physical properties), the specific sample sizes used for testing are not provided. The data provenance is described as being generated from various tests performed by Kuraray Medical Inc. and compared against their own and other manufacturers' predicate devices. The country of origin of the data would be Japan, where Kuraray Medical Inc. is based. The studies would be considered prospective for the "CLEARFIL SE BOND PLUS" device, as they were conducted to support its 510(k) submission.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    This information is not applicable. The document describes laboratory-based testing of material properties, not an evaluation requiring expert consensus on a test set to establish ground truth in an AI/diagnostic context.

    4. Adjudication Method for the Test Set

    This information is not applicable. There was no adjudication method described as it pertains to expert reviews of a test set, which is common in AI studies.

    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

    No. This is a submission for a dental adhesive system, not an AI or diagnostic device that would involve human readers or MRMC studies.

    6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

    No. This document does not describe an algorithm or AI device.

    7. The Type of Ground Truth Used

    The "ground truth" in this context refers to the established scientific standards and methods for evaluating biomaterial properties (e.g., ISO standards for biocompatibility), and comparative performance against legally marketed predicate devices. For bond strength and physical properties, the "ground truth" is derived from quantitative measurements obtained through standardized laboratory tests.

    8. The Sample Size for the Training Set

    This information is not applicable, as this is not an AI/machine learning device. The term "training set" is not relevant here.

    9. How the Ground Truth for the Training Set was Established

    This information is not applicable, as this is not an AI/machine learning device.

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