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510(k) Data Aggregation

    K Number
    K190940
    Device Name
    Tokuyama Rebase III
    Manufacturer
    Tokuyama Dental Corporation
    Date Cleared
    2019-10-04

    (177 days)

    Product Code
    EBI,CLA
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Tokuyama Rebase III

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

    The TOKUYAMA REBASE III device is for relining dentures and extension of denture borders.

    Device Description

    The TOKUYAMA REBASE III device is an acrylic resin used for chairside hard denture linings and extension of denture borders. The powder contains poly(ethyl methacrylate) and benzoyl peroxide. The liquid contains methacrylate monomer. The REBASE adhesive contains ethyl acetate, acetone and methacrylate polymer. The REBASE adhesive is used solely for bonding to acrylic surfaces, and cannot be used to bond nylon, metal, and silicone surfaces, etc. The device is composed of both a powder and liquid that is cured by chemical polymerization. The powder is packaged in a plastic bottle, and the liquid is packaged in a glass bottle. A group of polymerization agents of the device is contained in the powder and liguid separately to avoid the reaction during storage, and the polymerization reaction starts by mixing the powder and liquid. The device is cured by polymerization of methacrylic monomers contained in the liquid. The TOKUYAMA REBASE III kit contains powder, liquid, REBASE adhesive, TOKUSO RESIN HARDENER II, and other accessories, namely, a measuring cup, dropper, rubber cup, spatula, drip nozzle, drip cup, brush, and spoon. The device does not come sterile and is not intended to be sterilized prior to use. The powder comes in "fast" and "normal" depending on the desired setting time, and in three shades designated as Light Pink, Pink, and Live Pink.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device called "TOKUYAMA REBASE III," which is a denture relining, repairing, or rebasing resin. It aims to demonstrate substantial equivalence to a predicate device. The information requested regarding acceptance criteria and study details for an AI/ML device is not directly applicable to this type of submission for a physical material.

    However, I can extract the relevant information from the document considering the nature of the device (a material used in dentistry):

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document refers to adherence to international and Japanese standards for physical properties. Instead of a direct "acceptance criteria" table in the context of AI/ML performance metrics (like sensitivity, specificity), the acceptance is based on meeting the requirements of these standards.

    CharacteristicAcceptance Criteria (Standard Compliance)Reported Device Performance (TOKUYAMA REBASE III)
    ISO 20795-1: 2013Conforms to the standard for hard relining materials.Conforms to the standard for each characteristic (surface characteristics, polishability, shape capability, color stability, translucency, porosity, water sorption, and water solubility).
    Surface CharacteristicsAs per ISO 20795-1Conforms to standard
    PolishabilityAs per ISO 20795-1Conforms to standard
    Shape CapabilityAs per ISO 20795-1Conforms to standard
    Color StabilityAs per ISO 20795-1Conforms to standard
    TranslucencyAs per ISO 20795-1Conforms to standard
    PorosityAs per ISO 20795-1Conforms to standard
    Water SorptionAs per ISO 20795-1Conforms to standard
    Water SolubilityAs per ISO 20795-1Conforms to standard
    JIS T 6521:2005Conforms to the standard for "Denture Base Hard Relining Materials."Conforms to the standard for each characteristic (consistency, peak temperature, porosity and defects, surface gloss, water sorption, water solubility, and hardness).
    ConsistencyAs per JIS T 6521Conforms to standard
    Peak TemperatureAs per JIS T 6521Conforms to standard
    Porosity and DefectsAs per JIS T 6521Conforms to standard
    Surface GlossAs per JIS T 6521Conforms to standard
    Water SorptionAs per JIS T 6521Conforms to standard
    Water SolubilityAs per JIS T 6521Conforms to standard
    HardnessAs per JIS T 6521Conforms to standard
    Shelf Life3 years at 0-25°C (32-77F°) based on JIS T 6521. No deterioration in flexural properties.Real-time shelf-life testing established 3 years, expected no deterioration as per ISO criteria.
    BiocompatibilityConforms to ISO 10993-1: 2009 and FDA guidance for biological evaluation. No new biocompatibility risk.Concluded no new biocompatibility risk through comparison with existing devices using already cleared ingredients. No further biocompatibility tests conducted.

    2. Sample Size for Test Set and Data Provenance:

    The document does not specify exact "sample sizes" for the material testing in the way an AI/ML study would specify test cases. Instead, it indicates that testing was performed "based on ISO 20795-1: 2013" and "in accordance with JIS T 6521:2005," implying adherence to the sample size and methodology requirements of these standards. The data provenance is not explicitly stated as country of origin of data or retrospective/prospective, but it refers to tests conducted by Tokuyama, the device manufacturer.

    3. Number of Experts and Qualifications:

    Not applicable. This is a material science and biocompatibility assessment, not a diagnostic or AI-assisted interpretation task involving expert readers.

    4. Adjudication Method:

    Not applicable. The evaluation is based on objective measurements against specified standards for material properties.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    No. This is a 510(k) submission for a physical material, not an AI-assisted diagnostic device that would involve human readers.

    6. Standalone (Algorithm Only) Performance:

    Not applicable. There is no algorithm or AI component in this device.

    7. Type of Ground Truth Used:

    The "ground truth" for this device consists of established international (ISO 20795-1: 2013, ISO 10993-1: 2009) and national (JIS T 6521:2005) standards for dental materials. Compliance with these standards using specified test methods serves as the basis for performance evaluation and safety.

    8. Sample Size for the Training Set:

    Not applicable. This is not an AI/ML device requiring a training set.

    9. How the Ground Truth for the Training Set Was Established:

    Not applicable. There is no training set for this device.

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