LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K170894

    Validate with FDA (Live)

    Device Name
    Zirconia Dental Ceramics
    Manufacturer
    CHENGDU BESMILE BIOTECHNOLOGY CO.,LTD.
    Date Cleared
    2017-08-01

    (127 days)

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

    Zirconia Dental Ceramics are intended for crowns, multiunit bridges. Application includes both anterior and posterior bridges.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding "Zirconia Dental Ceramics." It primarily addresses the substantial equivalence determination for the device and its indications for use.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1