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510(k) Data Aggregation

    K Number
    K101504
    Device Name
    TI-CORE FLOW
    Manufacturer
    ESSENTIAL DENTAL SYSTEMS, INC.
    Date Cleared
    2010-10-29

    (150 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K083326,K053040,K922251
    Why did this record match?
    Device Name :

    TI-CORE FLOW

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

    Ti-Core® Flow+ is indicated for vital or non-vital tooth core build-up (replacement of existing restorations and/or lost tooth structure), as a base prior to fabricating an indirect restoration, and as a post cement. Ti-Core® Flow+ is also indicated for cementing of endodontic posts, crowns, bridges, inlays, onlays, and for core build-ups.

    Device Description

    Ti-Core® Flow+ is a dual-cure resin cement that can be used as a luting agent and core material. It is packaged in the familiar double-barrel syringe and our materials with the puttless other dental materials. The steps required to oroperly express the cement are: remove cap, attach mixer, attach dispensing tip, press plunger. After use, the mixer/dispensing tip should be discarded and the cap replaced.

    The contents of the kit are
    2 - Dual chambered syringes each containing 9 am resin cement

    • 20 Mixers
      10 - Thin dispensing tips
      10 - Thick dispensing tips
    AI/ML Overview

    The provided document describes the acceptance criteria and the study conducted for the Ti-Core® Flow+ dental resin cement.

    Acceptance Criteria and Device Performance

    Acceptance Criteria (ISO Standard 4049)Reported Device Performance (Ti-Core® Flow+)Details
    Film thicknessMeets or exceeds ISO specificationNon-clinical performance testing conducted.
    Working and setting timeMeets or exceeds ISO specificationNon-clinical performance testing conducted.
    Sensitivity to ambient lightMeets or exceeds ISO specificationNon-clinical performance testing conducted.
    Depth of cureMeets or exceeds ISO specificationNon-clinical performance testing conducted.
    Flexural strengthMeets or exceeds ISO specificationNon-clinical performance testing conducted.
    Water solubility and sorptionMeets or exceeds ISO specificationNon-clinical performance testing conducted.
    RadiopacityDoes not meet due to "not claimed"The device's radiopacity is not claimed and thus does not meet the specification, but this is presented as acceptable.

    Study Information

    1. Sample size used for the test set and the data provenance:
      The document does not specify a distinct "test set" in the traditional sense for a clinical study. The performance evaluation was based on non-clinical tests conducted according to ISO standard 4049. The sample size for these non-clinical tests (e.g., number of specimens for film thickness, flexural strength) is not provided. The provenance of these non-clinical test materials (e.g., origin of the raw materials, specific lab where tests were conducted) is also not explicitly stated, though it's implied the testing was done by Essential Dental Systems or a contracted lab.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
      Not applicable. This was a non-clinical, in-vitro study based on ISO standard specifications, not a study requiring expert clinical ground truth assessment on human data.

    3. Adjudication method for the test set:
      Not applicable. This was a non-clinical, in-vitro study.

    4. 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 document pertains to a dental resin cement, not an AI-powered diagnostic device, and no human reader studies are described.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
      Not applicable. This is not an algorithm or AI device.

    6. The type of ground truth used:
      The "ground truth" for evaluating the device's performance against its acceptance criteria was the ISO standard 4049 specification limits for various physical and chemical properties of dental resin cements.

    7. The sample size for the training set:
      Not applicable. This is not a machine learning or AI device that requires a training set.

    8. How the ground truth for the training set was established:
      Not applicable. There is no training set for this device.

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