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510(k) Data Aggregation

    K Number
    K022999
    Device Name
    CLEARFIL AP-X PLT INTRO KIT
    Manufacturer
    KURARAY MEDICAL INC.
    Date Cleared
    2002-10-24

    (45 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K012442,K012740
    Why did this record match?
    Reference Devices :

    K012442, K012740

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

    CLEARFIL AP-X PLT INTRO KIT is indicated for the following applications:

    1. Class I, II, V restorations of posterior teeth

    2. Class III, IV, V restorations of anterior teeth

    3. Cervical cavities or defects involving root surfaces

    Device Description

    This product is classified into Tooth shade Resin Material, CFR 29 Section 872.3690, because it is a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth. This device is combination of CLEARFIL AP-X PLT and CLEARFIL SE BOND (K012442). CLEARFIL AP-X PLT is substantially same to CLEARFIL AP-X(K012740) manufactured by Kuraray Medical Inc. on the technological characteristics, chemical ingredients and safety.

    AI/ML Overview

    The provided text is a 510(k) premarket notification for a dental material (CLEARFIL AP-X PLT INTRO KIT). It focuses on establishing substantial equivalence to predicate devices based on technological characteristics, chemical ingredients, and safety. This type of submission is not a clinical study report for a diagnostic AI device, and therefore, none of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or human reader performance is available in the provided text.

    The document is a regulatory filing stating that the device is "substantially equivalent" to existing, legally marketed dental materials. This means the manufacturer is asserting that the new device is as safe and effective as a predicate device without needing new clinical performance data because its fundamental properties and intended use are similar.

    Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details. The input text does not contain information about:

    1. Acceptance Criteria/Reported Device Performance: No performance metrics (e.g., sensitivity, specificity, accuracy, F1 score) are mentioned, nor are any acceptance criteria for such metrics.
    2. Sample Size and Data Provenance: No test set or training set data is described.
    3. Number of Experts/Qualifications/Adjudication: No human experts were involved in establishing ground truth for performance, as no performance study is described.
    4. MRMC Comparative Effectiveness Study: Not applicable, as this is a dental material, not an AI diagnostic device.
    5. Standalone Performance: Not applicable.
    6. Type of Ground Truth: Not applicable, as there's no performance study to establish ground truth for.
    7. Training Set Sample Size: Not applicable.
    8. Training Set Ground Truth Establishment: Not applicable.
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