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    K Number
    K221051
    Device Name
    Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
    Manufacturer
    Changsha Honchon Technology Co., LTD
    Date Cleared
    2022-07-08

    (88 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K141724
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

    Device Description

    Dental Zirconia Blank are derived from zirconia powder that has been processed into their final shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+ Y2O3+ HfO2+ Al2O3 with its composition conforms to ISO 13356, Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

    Dental Zirconia Pre-Shaded Blank are derived from the same Zirconia powder as the regular Dental Zirconia Blank with the addition of very small amount of inorganic pigments before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

    AI/ML Overview

    This document describes the premarket notification for the "Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank" device, which is a Class II device (Product Code: EIH). The submission aims to establish substantial equivalence to a predicate device (K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank).

    Here's an analysis of the acceptance criteria and study information provided:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are primarily based on established international standards for ceramic dental materials and biocompatibility. The reported device performance indicates that the device meets these standards.

    Acceptance Criterion (Standard)Reported Device Performance and Acceptance
    Material Composition
    Zirconia composition conforms to ISO 13356 for Y-TZP.Reported: Zirconia powder composed of ZrO2+ Y2O3+ HfO2+ Al2O3 with its composition conforms to ISO 13356. (Pass)
    Regular Blanks: Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3) ≥ 99.0%Reported: Regular Blanks: Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3) ≥ 99.0%. (Pass - stated as higher than predicate and passed biocompatibility and performance testing)
    Pre-Shaded Blanks: Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3) ≥ 99.0%Reported: Pre-shaded Blanks: Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3) ≥ 99.0%. (Pass - stated as higher than predicate and passed biocompatibility and performance testing)
    Inorganic pigments for pre-shaded blanks
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