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510(k) Data Aggregation

    K Number
    K182068
    Device Name
    Erran Dental Zirconia
    Manufacturer
    Hangzhou Erran Technology Co., Ltd.
    Date Cleared
    2018-12-13

    (134 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K111291
    Predicate For
    K192262
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    Normally, Erran Dental Zirconia are offered in blocks and powder and the size as shown below in Table 5-1, and are similar to the sizes and shapes of the predicate device.

    There are two types of our device, one is block, another is powder. The main difference is that the blocks are made by powder, zirconia blocks is prepared and have a fixed shape, while zirconia powder is used to directly product the shape of the tooth.

    Erran Dental Zirconia are derived from Zirconia powder that has been processed into their final net shapes. Erran Dental Zirconia have are then being further fabricated in to all-ceramic restoration such as crowns, bridge, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+Y2O3+HfO2+Al2O3 with its composition conforms to ISO13356-2015, Implants for Surgery-Ceramic Materials Based in Yttria-Stabilized Tetragonal Zirconia(Y-TZP). The performance of the dental zirconia conforms to ISO 6872-2015, Dentistry: Ceramic Materials.

    AI/ML Overview

    The provided text describes the acceptance criteria and a study conducted for the Erran Dental Zirconia device. Here's a breakdown of the requested information:

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

    ItemAcceptance CriteriaReported Device PerformanceConclusion
    Chemical Composition (%)Meet the ISO 13356-2015ZrO2+HfO2 ≥99 +Y2O3; Y2O3 4.5~6.6; HfO2 ≤5; Al2O3 ≤0.5; SiO2 ≤0.3; Fe2O3 ≤0.2Meet the ISO 13356-2015
    AppearanceThere is no spot cracks and foreign matter on the surface of Erran Dental Zirconia.There is no spot cracks and foreign matter on the surface of Erran Dental Zirconia.Conform
    Size (mm)The size deviation of zirconia blocks is within 1.0mm. The weight deviation of zirconia powder is within 10g.Meet the requirement.Conform
    Density (g/cm³)Not less than 2.6, the deviation is less than 0.05 compared with marked value (3.16).Meet the requirement.Conform
    Sintering Density (g/cm³)Not less than 6.026.025Conform
    Fracture Toughness (post sintering) (MPa)At least 8 samples of the 10 samples have a fracture toughness greater than 800The samples met the criteria.Conform
    Chemical Solubility (µg/cm²)
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