LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K242702
    Device Name
    VioSeal
    Manufacturer
    SPIDENT CO., LTD.
    Date Cleared
    2024-11-07

    (59 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K960548
    Why did this record match?
    Device Name :

    VioSeal

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

    Permanent obturation of root canals of the permanent teeth in combination with root canal points

    Device Description

    VioSeal is the epoxy resin-based root canal sealer in the dual syringe for easy mixing and injection and is mixed with the 1:1 mixing ratio. It contains inorganic fillers which has good biocompatibility, physical and chemical properties and produces a complete obturation. Therefore, VioSeal has good biocompatibility with the root canal tissues.

    AI/ML Overview

    The provided text does not describe an AI/ML powered medical device or software. It pertains to a dental device, specifically a root canal filling resin. Therefore, the questions regarding acceptance criteria, study details, ground truth, sample sizes, and expert qualifications for an AI/ML device are not applicable to this document.

    The document discusses the substantial equivalence of the VioSeal root canal filling resin to a predicate device based on non-clinical tests.

    Here's the relevant information found in the document regarding the device's performance:

    1. Table of Acceptance Criteria and Reported Device Performance:

    TestAcceptance Criteria (ISO 6876)Reported Device Performance (VioSeal)
    FlowabilityMeets ISO 6876 requirementsMeets ISO 6876 requirements
    Working TimeMeets ISO 6876 requirementsMeets ISO 6876 requirements
    Setting TimeMeets ISO 6876 requirementsMeets ISO 6876 requirements
    Film ThicknessMeets ISO 6876 requirementsMeets ISO 6876 requirements
    SolubilityMeets ISO 6876 requirementsMeets ISO 6876 requirements
    Radio-opacityMeets ISO 6876 requirementsMeets ISO 6876 requirements
    BiocompatibilityGood biocompatibilityGood biocompatibility

    2. Study that Proves the Device Meets Acceptance Criteria:

    A non-clinical study investigated the performance of VioSeal according to ISO 6876 standards for root canal filling materials.

    • Sample size used for the test set and the data provenance: Not explicitly stated, but implies laboratory testing of the material itself. It is a non-clinical study, not a study involving human or image data.
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a materials science characterization, not an expert-driven ground truth assessment.
    • Adjudication method: Not applicable.
    • Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI/ML or diagnostic device.
    • Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
    • Type of ground truth used: The "ground truth" or reference standard for these non-clinical tests is the established methodology and specifications outlined in the ISO 6876 standard.
    • Sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
    • How the ground truth for the training set was established: Not applicable.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1