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510(k) Data Aggregation

    K Number
    K152373
    Device Name
    VITA VM LC Flow
    Manufacturer
    VITA ZAHNFABRIK H. RAUTER GMBH & CO.
    Date Cleared
    2015-12-30

    (131 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    K123304,K992645,K961434
    Why did this record match?
    Reference Devices :

    K123304, K992645

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Full and partial veneering of metal frameworks: crowns, bridges, telescopic crowns, implant superstructure
    • Individualization of and layering on VITA ENAMIC®
    • Layering-over long-term temporaries made from VITA CAD-Temp®
    • Individualization of acrylic teeth
    • Reproduction of gingival components
    • Metal-free crowns and three-unit anterior bridges as long-term temporary restorations
    • Veneering of removable and partially removable dentures (according to the manufacturer's information)
    • Inlays
    • Veneers
    Device Description

    VITA VM LC Flow is a light-cured microparticle indirect composite material for fixed and removable restorations for extraoral fabrication.

    AI/ML Overview

    This document describes the VITA VM® LC Flow, a dental veneering material. It does not describe an AI/ML powered device, therefore, the requested information elements related to AI/ML device testing (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, and ground truth establishment for training set) are not applicable.

    Here's the relevant information that can be extracted:

    Acceptance Criteria and Device Performance:

    The primary acceptance criteria mentioned are adherence to the FDA recognized standard, ISO 10477:2004(E) – Dentistry – Polymer-based crown and bridge materials. The device's performance is compared against this standard and predicate devices.

    Acceptance Criteria (from ISO 10477:2004(E))Reported Device Performance (VITA VM® LC Flow)Comparison with Predicate Devices (Examples)
    ISO 10477 – Physical Property requirementsAll PassAll predicate devices also pass
    Specific Physical Properties (bench testing):
    Flexural Strength135 MPaVITA Zeta: 95 MPa, SR Nexco: 90 ± 10 MPa, SINFONY: 105 MPa (VITA VM® LC Flow meets or exceeds all listed predicates)
    E-Modulus6600 - 7500 MPaVITA Zeta: 3450 MPa, SR Nexco: 6500 ± 500 MPa, SINFONY: 3100 MPa (VITA VM® LC Flow is comparable or higher than listed predicates)
    Water Absorption25.4 µg/mm³VITA Zeta: 28 - 30 µg/mm³, SR Nexco: 15 ± 1 µg/mm³, SINFONY: ≈ 20 µg/mm³ (VITA VM® LC Flow is within the range of performance of listed predicates)
    Water Solubility0.1 µg/mm³VITA Zeta: 0 µg/mm³, SR Nexco: 1 ± 0.5 µg/mm³, SINFONY: 0.5 µg/mm³ (VITA VM® LC Flow is comparable to listed predicates)
    BiocompatibilityVITA VM® LC Flow is biocompatible per assessment based on ISO 10933-1:2009 and ISO 7405:2008.All predicate devices are assumed to meet similar biocompatibility requirements for substantial equivalence.

    Study Information:

    1. Sample size used for the test set and the data provenance: Not explicitly stated for each specific test, but the testing was "bench testing" performed in accordance with ISO 10477:2004(E) – Dentistry – Polymer-based crown and bridge materials standard. The country of origin for the data is not specified, but the submitter is based in Germany. The data is retrospective as it refers to performance data from tests conducted prior to the submission.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device relying on expert interpretation of results. The "ground truth" for the physical property tests is based on the methods described in the ISO standard.

    3. Adjudication method for the test set: Not applicable.

    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.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the device's performance validation is based on the physical and chemical property testing methodologies outlined in the ISO 10477:2004(E) and related biocompatibility standards (ISO 10933-1:2009, ISO 7405:2008). These are objective measurements rather than expert consensus or patient outcomes.

    7. The sample size for the training set: Not applicable as this is not an AI/ML device.

    8. How the ground truth for the training set was established: Not applicable.

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