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510(k) Data Aggregation

    K Number
    K193434
    Device Name
    VITA LUMEX AC
    Date Cleared
    2020-07-21

    (223 days)

    Product Code
    Regulation Number
    872.6660
    Panel
    Dental
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    VITA LUMEX AC

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

    VITA Lumex® AC is used to veneer the following:

    • Full and partial veneering of zirconia
    • Full and partial veneering of lithium disilicate
    • Partial veneering of feldspar ceramic
    • Reconstruction without a substructure
      Materials:
    • Zirconia substructures (CTE approx. 10.0 to 10.5 x 10-6 K-1)
    • Glass-ceramic substructures (CTE approx. 9.0 to 10.5 x 10-6 K-1)
    Device Description

    VITA Lumex® AC is a natural low-fusing veneering ceramic system that is suitable for veneering all ceramic substructures. VITA LUMEX AC standard layering consists of the two Materials DENTINE and ENAMEL. The color-bearing DENTINE materials, which provide good coverage, offer the perfect precondition for the preparation of veneers with intensive shades. With this two-layer alternative, VITA offers an ideal solution for the reproduction of optimal shade results in case of thin walls. Additionally, the intensive shade effect of the DENTINE permits a more generous use of the ENAMEL materials, which create the desired translucency. The user is able to prepare a natural restoration with a lifelike appearance with only two layers. This product is provided non-sterile in glass jars in a powder form to be used in conjunction with the Vita low fusing liquid.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for the VITA Lumex® AC, a porcelain powder for clinical use, and not a study describing the acceptance criteria and performance of a device that meets those criteria.

    Therefore, I cannot provide the requested information, which includes:

    • A table of acceptance criteria and reported device performance.
    • Sample size used for the test set and data provenance.
    • Number of experts and their qualifications for establishing ground truth.
    • Adjudication method for the test set.
    • MRMC comparative effectiveness study results.
    • Standalone (algorithm-only) performance.
    • Type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.

    The document states: "Non-Clinical Performance Testing" on page 5, indicating that "Bench test results allowed us to conclude that VITA Lumex® AC is substantially equivalent to the predicate device for its intended use." It also explicitly states "Clinical Performance Data: Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA Lumex® AC."

    This filing relies on bench testing and comparison to predicates, not specific clinical performance studies with acceptance criteria as requested in your prompt.

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