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510(k) Data Aggregation

    K Number
    K191631
    Date Cleared
    2019-11-01

    (135 days)

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

    ZMAXX Dental Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

    Device Description

    Dental Zirconia Blank is available in various specifications, which are combinations of height (1225mm), color model (0M1/A1 A3/B1B4/C1C4/D2~D4) and transparency model (T45).

    AI/ML Overview

    This document describes the 510(k) premarket notification for ZMAXX Dental Zirconia Blanks (K191631). It does not pertain to an AI/ML powered medical device, therefore many of the requested categories (such as experts, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable.

    Here's the information directly related to the acceptance criteria and study as presented:


    Acceptance Criteria and Device Performance for ZMAXX Dental Zirconia Blanks (K191631)

    This submission is for a medical device (ZMAXX Dental Zirconia Blanks) which is a physical material used for dental restorations, not an AI/ML software device. Therefore, the "acceptance criteria" and "device performance" are primarily based on meeting established industry standards for dental ceramic materials and demonstrating bio-compatibility, rather than performance metrics typically associated with AI/ML systems (e.g., accuracy, sensitivity, specificity).

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly defined by compliance with relevant ISO standards and a comparison to a predicate device.

    Characteristic / TestAcceptance Criteria (Implicit from Standards/Predicate)Reported Device Performance (ZMAXX Dental Zirconia Blanks)
    Performance Test (per ISO 6872:2015)Comply with ISO 6872:2015, Dentistry-Ceramic materials (e.g., strength requirements for Type II Class 5)Comply with ISO 6872 (specifically, it is Type II Class 5)
    Density TestComparable to predicate device (6.00 g/cm³)6.00 g/cm³
    Cytotoxicity (per ISO 7405:2008)No adverse reaction identifiedTested; no adverse react identified
    Intracutaneous Reactivity (per ISO 10993-10:2010)No adverse reaction identifiedTested; no adverse react identified
    Sensitization (per ISO 10993-10:2010)No adverse reaction identifiedTested; no adverse react identified
    Acute Systematic Toxicity (per ISO 10993-11:2006)No adverse reaction identifiedTested; no adverse react identified
    Genotoxicity (per ISO 10993-3:2014)No adverse reaction identifiedTested; no adverse react identified
    Chemical Composition (Weight %)ZrO₂ >99.0%, Inorganic Pigment (Al₂O₃, SiO₂, Fe₂O₃, Er₂O₃) 99.0%, Inorganic Pigment (Al₂O₃, SiO₂, Fe₂O₃, Er₂O₃)
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