Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K211308
    Device Name
    INNI-CERA
    Manufacturer
    Date Cleared
    2021-10-04

    (158 days)

    Product Code
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aon Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1