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    K Number
    K965091
    Device Name
    TEETHMATE F-1
    Manufacturer
    KURARAY COMPANY, LTD.
    Date Cleared
    1997-03-27

    (98 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K910424,K943170
    Why did this record match?
    Reference Devices :

    K910424, K943170

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

    This device is used as a sealing material for pit and fissure. This intended use is same to that of similar products which are identified in the paragraph 4.

    Device Description

    This product is classified into the pit and fissure sealant and conditioner, CFR 21 Section 872.3765, because it is a device composed of resin, such as polymethyl methacrylate, intended for use primary in young children to seal pit and fissure depressions in the biting surfaces of teeth to present cavities.

    AI/ML Overview

    This document describes the safety evaluation of TEETHMATE F-1, a pit and fissure sealant. It focuses on the biocompatibility of a new ingredient, TMDPO, as well as the leachables from the cured resin. The study is a series of in vitro and in vivo toxicology tests.

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance CriteriaReported Device Performance
    Acute Toxicity of TMDPO (LD50)Not explicitly stated, but typically a high LD50 indicating low toxicity.LD50 > 4,000 mg/kg (indicating low acute toxicity)
    Subacute Toxicity of TMDPONegative (no adverse effects observed)Negative (no adverse effects observed at 13mg/kg/day over 25 days)
    Genotoxicity (Ames Test) of TMDPONegative (no mutagenic activity)Negative across all tested bacterial species for both direct and metabolic activity tests
    Amount of TMDPO Leached from Cured ResinNot explicitly stated, but implicitly a very low or undetectable amount for safety.Less than identification limit (0.04 ppm) for both 37°C and 50°C conditions
    Acute Toxicity of Leachables (effect on mouse weight and mortality)No significant effect on mouse weight and no mortality.No effect on mouse weight and no mouse died.

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

    • Acute Toxicity of TMDPO: Mice were used. Specific number not provided, but typically a small group for LD50 determination.
    • Subacute Toxicity Test: Rats were used. Specific number not provided, but typically a group for control and various doses.
    • Genotoxicity Test (Ames Test): Bacterial species (Escherichia coli WP2 uvrA and Salmonella typhimurium TA100, TA1535, TA98, TA1537) were used. These are in vitro tests, not animal or human subjects.
    • Amount of TMDPO Leached from Cured Resin: Two pieces of cured resin (10mm Φ × 5mm) were tested separately for each condition (37°C and 50°C). This is an in vitro test.
    • Acute Toxicity of Leachables: ICR mice were used. The number of mice is not explicitly stated, but implied to be sufficient for a toxicity study. Approximately 44 cylindrical specimens of cured resin (3mm Φ × 3mm) were used per gram of specimen for extraction. This is an in vivo test.

    Data Provenance: All studies were conducted by Kuraray Co., Ltd. or The Kitasato Institute, both located in Japan. The studies appear to be prospective toxicology and biocompatibility evaluations specifically designed for this device.

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

    This document describes toxicology and biocompatibility studies, not clinical efficacy or diagnostic accuracy studies that would typically involve a "ground truth" established by experts in that context. The "truth" in these studies is derived from laboratory measurements (e.g., LD50, ppm leached) and observed biological responses (e.g., animal health, genetic mutations). The expertise lies in toxicology and laboratory science, and the institutions conducting the tests (Kuraray Co., Ltd. and The Kitasato Institute) are expected to have qualified scientists and technicians to perform these studies according to standard protocols.

    4. Adjudication Method for the Test Set

    Not applicable. This is a toxicology and material leaching study, not a study involving human interpretation of data requiring adjudication.

    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

    Not applicable. This is not a diagnostic device or an AI-assisted device. It is a dental material (pit and fissure sealant).

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

    Not applicable. This is not an algorithm-based device.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    The "ground truth" in these studies is based on:

    • Toxicological endpoints: Survival, organ/tissue changes, genetic mutations as per established toxicology protocols.
    • Chemical analysis: Quantification of leached substances using analytical techniques like high-pressure liquid chromatography (HPLC).
    • Biocompatibility standards: Assessment against known biological responses to materials.

    8. The Sample Size for the Training Set

    Not applicable. This device is not an AI/machine learning device, so there is no concept of a "training set" in this context.

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

    Not applicable, as there is no training set for this device.

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