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510(k) Data Aggregation

    K Number
    K250778
    Device Name
    Sil-Flow
    Manufacturer
    DSI Dental Solutions Ltd
    Date Cleared
    2025-05-23

    (70 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K231696,K153493
    Why did this record match?
    Device Name :

    Sil-Flow

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

    Sil-Flow is indicated for
    [A] Temporary inlay and onlay treatments of the cavity
    [B] Sealing of openings for implant screws
    [C] Relining material for temporary crowns and bridges
    [D] Block-out material for retentive areas in the dental arch, e.g. before taking impressions
    [E] Covering of the gingival margin
    [F] Fixing of resin matrix during filling placement
    [G] Temporary filling of cavities

    Device Description

    Sil-Flow is a flowable light-cured temporary filling material used for filling and sealing.

    AI/ML Overview

    The provided FDA Premarket Notification (510(k)) for the Sil-Flow device is for a Tooth Shade Resin Material and NOT an AI/Software as a Medical Device (SaMD) product. Therefore, the information typically found in such a submission regarding AI device performance, such as:

    • Acceptance Criteria for AI performance metrics (e.g., sensitivity, specificity, AUC)
    • Study design for AI performance evaluation (e.g., standalone, human-in-the-loop, MRMC)
    • Sample size and data provenance for AI test sets
    • Ground truth establishment (number/qualifications of experts, adjudication methods)
    • Training set details for AI models
    • Effect size of AI assistance for human readers

    are not present in this document.

    This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (Clip Flow) based on physical and chemical properties, biocompatibility, and intended use for a dental material.

    Here's a breakdown of the requested information based on the provided document, highlighting what is present and what is absent from the perspective of an AI/SaMD device:

    Acceptance Criteria and Study Proving Device Meets Criteria (for Dental Material)

    The acceptance criteria and supporting study for Sil-Flow relate to its physical, chemical, and biological properties as a tooth shade resin material, demonstrating its safety and performance for its indicated uses.

    1. A table of acceptance criteria and the reported device performance

    Test ParameterAcceptance Criteria (from ISO 4049 Protocol)Reported Device PerformanceComments
    Physical/Chemical Properties
    Visual Appearance(Implied to meet standard)Met criteria"All test results met the criteria in the standard."
    Depth of Cure (mm)Not explicitly stated (but referenced ISO 4049)3.1 mmPredicate device (Clip Flow) reported 11mm, suggesting a difference. However, "Both the subject devices and the predicate device have physical parameters which meet the requirements of the relevant ISO standards," implying 3.1mm is acceptable per the standard for Sil-Flow.
    Shor Hardness DNot explicitly stated52 Shor DPredicate (Clip Flow) reported 90 Shore A. Note the difference in Shore scale (D vs. A), making direct comparison difficult without a conversion or further context, but still stated to meet relevant ISO standard.
    Sensitivity to Ambient Light(Implied to meet standard)Met criteria"All test results met the criteria in the standard."
    Water Sorption (µg/mm³)
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