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510(k) Data Aggregation

    K Number
    K141047
    Device Name
    LC CALCIUMHYDROXIDE LINER
    Manufacturer
    S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN
    Date Cleared
    2015-04-14

    (356 days)

    Product Code
    EJK
    Regulation Number
    872.3250
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LC CALCIUMHYDROXIDE LINER

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

    LC Calcium Hydroxide Liner is intended for:

    • Application to dentin as a protective barrier between restorative materials and deep vital dentin (indirect pulp capping)
    • lining of cavities for following filling procedures
    Device Description

    LC Calcium Hydroxide Liner is a radiopaque one component visible light curing liner containing calcium hydroxide. It is intended for indirect pulp capping and for lining of cavities where filling procedures will follow and can be applied in thin layers followed by light curing of the material. The chemical components include fillers, resins, an alkalining agent, as well an initiator.

    AI/ML Overview

    This document is a 510(k) premarket notification for a dental device, specifically a calcium hydroxide liner, and does not contain information about an AI-powered device or a study involving AI. Therefore, I cannot provide the requested information.

    The document discusses "LC Calcium Hydroxide Liner" and focuses on:

    • Regulatory information: Classification, product code, and substantial equivalence to a predicate device (Calcimol LC, VOCO GmbH, K 924182).
    • Device description: White paste, light-cure, for indirect pulp capping and cavity lining.
    • Performance data: Non-clinical tests like working time, barcol hardness, pH-value, water sorption, water solubility, flexural strength, and depth of cure, all tested according to ISO 4049. These are standard material property tests for dental composites, not AI-related evaluations.
    • Technological characteristics: Comparison with the predicate device, highlighting similarities in appearance, delivery form, polymerization, application, and general ingredients. It mentions a reformulation of the subject device with different quantities of chemical components, and that performance testing was done to validate this change.

    There is no mention of:

    • Acceptance criteria for an AI device
    • Any study involving AI (e.g., comparative effectiveness study, standalone algorithm performance)
    • Sample sizes for AI test/training sets
    • Expert ground truth establishment or adjudication methods for AI
    • Effect sizes of AI assistance

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI device meets them.

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