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510(k) Data Aggregation

    K Number
    K221811
    Device Name
    Vista BC Sealer
    Manufacturer
    Inter-Med, Inc.
    Date Cleared
    2022-11-21

    (152 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K080917,K170175
    Why did this record match?
    Device Name :

    Vista BC Sealer

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

    Permanent obturation of the root canal following vital pulp-extirpation.
    Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.

    Device Description

    Vista BC Sealer is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. Vista BC Sealer is an insoluble, radiopaque material based on a calcium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Sealer does not appreciably shrink during setting and demonstrates excellent physical properties. Vista BC Sealer is packaged in a preloaded syringe and supplied with disposable single use application tips.

    AI/ML Overview

    The provided text describes the 510(k) submission for the Vista BC Sealer, a root canal filling material. It details non-clinical performance testing but does not include information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML algorithm or a typical clinical study with a test set, ground truth, or expert involvement. The submission focuses on demonstrating substantial equivalence to predicate devices through physical, chemical, and biocompatibility testing.

    Therefore, many of the requested fields regarding acceptance criteria, study design for AI/ML, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies cannot be answered from the provided document as they are not relevant to this type of device clearance.

    However, I can extract the information related to the performance demonstrated by the non-clinical tests.

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

    The document does not explicitly state numerical acceptance criteria for many of the tests in a table format, but it does state compliance with ISO standards and favorable comparison to the predicate device. Where specific values or qualitative outcomes are mentioned, they are included below.

    Test CategoryAcceptance CriteriaReported Device Performance
    Shelf-Life TestingNot explicitly stated; implied to meet typical storage conditions.Through accelerated shelf life testing, Vista BC Sealer was found to have a shelf-life of two years. Real-time aging is being performed to support this.
    ISO 6876 TestingCompliance with ISO 6876 (standards for flow, set time, film thickness, solubility/degradation, radiopacity).Performed very similarly to the predicate device, ENDOSEAL MTA, thereby confirming substantial equivalence for: * Flow testing * Set time testing (Vista BC Sealer:
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