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510(k) Data Aggregation

    K Number
    K221429
    Device Name
    KDF Zirconia Disc
    Manufacturer
    DENKEN-HIGHDENTAL Co., Ltd.
    Date Cleared
    2022-07-14

    (59 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K171585,K192262
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    KDF Zirconia Disc is indicated for the production of dental ceramic restorations, specifically inlays, onlays, veneers, artificial teeth, crowns and bridges, which is manufactured by CAD / CAM processing. The application includes both anterior teeth and posterior teeth areas. All blocks are processed by a dental laboratory or dental technician.

    Device Description

    KDF Zirconia Disc is used for custom made dental restorations using a CAD/CAM system by dental professionals. The subjected device has disc shapes and various shades and thicknesses as follow.
    KDF Zirconia Disc is mainly composed of zirconium oxide (ZrO2) and contain other oxides as stabilizers or/and colorants. The device is two different classifications according to ISO 6872: 2015 depending on shades. MU series are classified as type II class 4 ceramic, otherwise are classified as type II class 5 ceramic.

    AI/ML Overview

    I am sorry, but I cannot answer your request for specific details regarding the Acceptance Criteria and Study that proves the device meets the Acceptance Criteria using the provided text. The document provided outlines a 510(k) premarket notification for a dental ceramic restoration device (KDF Zirconia Disc) and includes non-clinical performance testing results against recognized standards (ISO 6872:2015 and ISO 10993 series). While it presents acceptance criteria and reported device performance in a table, it does not contain the following information you requested:

    • Sample sized used for the test set and the data provenance: The document states that "all samples" and "all fully sintered test articles" were tested, but does not provide a specific number. The origin of the data (country, retrospective/prospective) is not mentioned.
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This type of information is generally related to clinical studies or expert review for diagnostic devices, which is not applicable to this material device.
    • Adjudication method (e.g. 2+1, 3+1, none) for the test set: Again, this relates more to diagnostic device performance evaluation with expert review, which is not the context here.
    • If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This type of study is for AI-assisted diagnostic devices and is not relevant to a dental material device.
    • If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is also for AI/algorithm-based devices.
    • The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is defined by the technical specifications and criteria set forth in the ISO standards, not expert consensus or pathology data in the typical sense for diagnostic applications.
    • The sample size for the training set: The document does not describe any training set as it pertains to AI or machine learning. The "training" in this context would implicitly be the process of developing and manufacturing the zirconia disc to meet the ISO standards.
    • How the ground truth for the training set was established: As there is no "training set" in the context of an AI/machine learning device, this information is not provided.

    The provided text focuses on the physical and chemical properties of the KDF Zirconia Disc, demonstrating its compliance with international standards for dental ceramic materials and biocompatibility for establishing substantial equivalence to predicate devices. It does not involve AI, diagnostic performance, or human reader studies.

    Here is the table of acceptance criteria and reported device performance from the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test PerformedAcceptance CriteriaResultsJudgment
    Uniformity and Freedom from extraneous materialsNo pigment unbalance and foreign materials shall be found on any of the top, bottom, or side surfaces of the disc when visual inspection is made.No pigment unbalance and foreign material was identified.Passed.
    Activity Concentration<1.0 Bq/g of 238UThe radioactivity concentration (238U) of all samples was less than 1.0 Bq/g.Passed.
    Flexural StrengthMT series: ≥800 MPa MU series: ≥500 MPaThe flexural strength of MT series with fully sintering were all greater than 800 MPa; similarly for MU series, all test articles showed greater than 500 MPa.Passed.
    Chemical Solubility< 100 µg/cm2The chemical solubilities of all fully sintered test articles were all less than 100 µg/cm2.Passed.
    Coefficient of Thermal Expansion(10.7±0.5) ×10-6 K-1The coefficients of thermal expansion for all fully sintered test articles were all within the range of (10.7±0.5) ×10-6 K-1.Passed.
    Shrinkage FactorMT series: 1.2171.226±0.002 MU series: 1.2251.235±0.002The shrinkage factor of MT and MU with fully sintering showed 1.2171.226±0.002 and 1.2251.235±0.002, respectively.Passed.

    Regarding the other requested information:

    1. Sample sized used for the test set and the data provenance: Not explicitly stated. The document refers to "all samples" and "all fully sintered test articles." Data provenance (country of origin, retrospective/prospective) is not provided.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to this type of device (dental material). Ground truth is established by ISO standards.
    3. Adjudication method: Not applicable.
    4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not applicable to a material device.
    5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not applicable to a material device.
    6. The type of ground truth used: The ground truth for performance is based on the specifications and requirements defined in recognized international standards, specifically ISO 6872:2015 for dental ceramic materials and ISO 10993 series for biocompatibility.
    7. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
    8. How the ground truth for the training set was established: Not applicable.
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