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    K Number
    K180252
    Device Name
    Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank
    Manufacturer
    Crown Porcelain Dental Technology Co., Ltd.
    Date Cleared
    2018-04-24

    (84 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K160367
    Why did this record match?
    Applicant Name (Manufacturer) :

    Crown Porcelain Dental Technology Co., Ltd.

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

    Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

    Device Description

    Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank are available in discs shape, and in various specifications, which are combinations of height (1025mm), color model (0M1/A1A4/B1B4/C1C4/D2~D4) and transparency model (T41/T45/T49/TR).

    AI/ML Overview

    This document is a 510(k) Premarket Notification for a dental material, not a medical device involving AI or software. Therefore, the requested information about acceptance criteria, study details, and AI-specific metrics (like human reader improvement with AI assistance) is not applicable to this submission.

    Here's a breakdown of why many of your questions cannot be answered from the provided text:

    • No AI or Software: The device, "Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank," is a material for dental restorations. It does not involve any artificial intelligence, machine learning, or software components that would have performance metrics like sensitivity, specificity, or AUC, or require a ground truth established by experts.
    • No Diagnostic or Interpretive Task: This device is a component used in manufacturing, not a diagnostic tool that interprets data or images.
    • No Clinical Study for Performance Evaluation: The document explicitly states: "No clinical study is included in this submission." This means there is no human-in-the-loop performance evaluation or comparison against human experts.

    However, I can extract information related to the performance testing that was conducted for this material:

    Acceptance Criteria and Reported Device Performance

    The "acceptance criteria" here refer to the performance standards and biocompatibility tests for the material itself, not diagnostic accuracy. The reported device performance indicates conformance to these standards.

    1. Table of Acceptance Criteria and Reported Device Performance

    Test/CharacteristicAcceptance Criteria (Predicate)Reported Device Performance (Subject Device)
    Material Properties
    Type and Class perType II Class 5Type II Class 5
    ISO 6872:2015
    Chemical CompositionZrO2 ≥ 99.0%, Inorganic Pigment (Fe2O3, Er2O3) ≤ 1%ZrO2 > 99.0%, Inorganic Pigment (Al2O3, SiO2, Fe2O3, Er2O3)
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