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510(k) Data Aggregation

    K Number
    K152066
    Device Name
    Luminesse Anterior Zirconia AT
    Manufacturer
    TALLADIUM, INC.
    Date Cleared
    2015-10-21

    (89 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K143330
    Why did this record match?
    Device Name :

    Luminesse Anterior Zirconia AT

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

    Luminesse Anterior Zirconia blanks/discs are indicated for use with CAD/CAM technology or manual milling machines to produce all-ceramic custom dental restorations - full contour crowns and bridges for anterior location - as prescribed by a dentist.

    Device Description

    Luminesse Anterior Zirconia are used for full contour Zirconia dental restorations utilizing CAD/CAM system for design and manufactured. Once designed and manufactured, Luminesse Anterior Zirconia will undergo sintering. The anterior Zirconia products are pre-shaded to meet all 16 VITA® shading guide; hence, no further coloring is necessary post-sintering. Once sintered, Luminesse Anterior Zirconia will exhibit maximum strength anterior dental restorations.

    AI/ML Overview

    The provided text describes the Luminesse Anterior Zirconia device, which is a material used for dental restorations. The document is a 510(k) summary submitted to the FDA, indicating that the device is seeking substantial equivalence to a legally marketed predicate device.

    Here's an analysis of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (from ISO 6872)Reported Device Performance (Luminesse Anterior Zirconia)
    Flexural Strength: > 600 MPa (for anterior use)622 MPa (average)
    Coefficient of Thermal Expansion: Not explicitly stated, but compared to predicate.10.5 x 10^-6/K
    Density: Not explicitly stated, but compared to predicate.>6.05 g/cm³ (sintered)
    Biocompatibility:
    (1) Cytotoxic Tests (Agar diffusion test and filter diffusion test)(1) 0 level
    (2) Short-term systemic toxicity (oral route)(2) No systemic toxicity
    (3) Test for irritation and delayed-type hypersensitivity(3) No hypersensitivity
    (4) Hemolytic Test(4) Hemolysis rate, 600 MPa). For biocompatibility, standard toxicology and irritation tests are used to demonstrate safety, with acceptance criteria like "0 level" for cytotoxicity and "no systemic toxicity."

    8. The Sample Size for the Training Set

    This information is not applicable as this device is a material, not an AI/ML algorithm that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable for the same reason as point 8.

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