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510(k) Data Aggregation

    K Number
    K211308
    Device Name
    INNI-CERA
    Manufacturer
    Aon Co., Ltd
    Date Cleared
    2021-10-04

    (158 days)

    Product Code
    EIH,EBG
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K191590,K051705
    Predicate For
    K240419
    Why did this record match?
    Reference Devices :

    K191590

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

    INNI-CERA is indicated for use by dental technicians in the construction of custom made all ceramic restorations.

    Coping
    Crown
    Inlay & Onlay
    Veneer
    Bridge(3-unit anterior bridges)

    Device Description

    INNI-CERA is intended for use in fabricating custom-made ceramic restorations using a 3D printer additive manufacturing process. It is a product that is used after fabricating and sintering with a mixture of zirconia powder and binder. The DLP 3D printer used to fabricate the INNICERA is a photocuring lamination method using an STL file (dental restoration shape), which is irradiated with light in the strong UV region (420nm) to cure the photocurable mixture to form a model. This product corresponds to ISO 6872 Type I Class III. The material is used in a 3D printer, which prints the shape determined by an STL file converted from patients' teeth data. 3D printer is not included with the product. INNI-CERA cannot be reused.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a dental material, INNI-CERA. The submission focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against acceptance criteria in a typical clinical study with human readers or AI.

    Therefore, many of the requested categories for acceptance criteria and study details are not applicable in this context. The document primarily describes bench testing to ensure the material meets established standards for dental ceramics.

    Here's a breakdown of the applicable information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (ISO 6872 requirements)Reported Device Performance (INNI-CERA)
    Flexural Strength>300 MPa>300 MPa
    Chemical Solubility
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