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510(k) Data Aggregation

    K Number
    K150056
    Device Name
    Luxisse+
    Manufacturer
    HEANY INDUSTRIES INC
    Date Cleared
    2015-05-06

    (114 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K132070,K073314
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Heany Industries, Inc. "Luxisse +" is non-implantable Zirconia material intended for CAD/CAM fabrication of all ceramic dental restorations. The material is used for the manufacturing of inlays, veneers, single unit anterior and posterior crowns, and three unit anterior bridges.

    Device Description

    Heany Industries Inc. "Luxisse +" is an all ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a block or disk shape. CAD/CAM fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, single unit posterior and anterior crowns, and three unit anterior bridges. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer.

    AI/ML Overview

    The provided text describes the "Luxisse +" device, a Zirconia material for CAD/CAM fabrication of all-ceramic dental restorations. The document is a 510(k) summary for premarket notification to the FDA, asserting substantial equivalence to a predicate device, "Heany Industries, Inc. Dental Zirconia" (K073314).

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

    The acceptance criteria are derived from the consensus design standard ISO 6872:2008, "Dentistry - Ceramic Materials", and BS EN 1641:2004, "Dentistry, Medical Devices for Dentistry, Materials." The reported device performance is presented in "Table 2: Testing performed for the 'Luxisse + ' 510(k) Submission" and implicitly through the device comparison chart (Table 1) where specific values are listed.

    Test / Acceptance Criteria (Standard Reference: ISO 6872:2008 (E))Reported Device Performance ("Luxisse +")Comparison to Predicate (Dental Zirconia, where applicable)
    Radioactivity ConcentrationMet predefined criteria as specified in ISO 6872:2008 (E).Not explicitly stated for predicate in summary.
    Flexural StrengthMet requirements as specified in ISO 6872:2008 (E). (Specific value: 546 MPa)Predicate: 1200 MPa ± 150 MPa
    UniformityMet predefined criteria as specified in ISO 6872:2008 (E).Not explicitly stated for predicate in summary.
    Coefficient of Thermal Expansion (CTE)Met predefined criteria as specified in ISO 6872:2008 (E). (Specific value: $10 \times 10^{-6}/K$)Predicate: $10 \times 10^{-6}/K$
    Fracture Toughness (KIC)Met predefined criteria as specified in ISO 6872:2008 (E). (Specific value: 5.83 MPam^0.5)Predicate: 8 MPam^0.5
    Chemical Solubility in WaterMet predefined criteria as specified in ISO 6872:2008 (E). (Specific value:
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