LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K032081
    Device Name
    KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60
    Manufacturer
    KAVO AMERICA
    Date Cleared
    2003-07-24

    (17 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K022996
    Why did this record match?
    Device Name :

    KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60

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

    The KaVo Everest® ZS-Blank is used in the manufacture of dental prosthetics.

    Device Description

    The KaVo Everest® ZS-Blank is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics

    AI/ML Overview

    This 510(k) submission for the KaVo Everest® ZS-Blank does not include a study or acceptance criteria related to a performance study of the device.

    Instead, the submission states:

    Performance Data: "None required. The claim of substantial equivalence is based on comparisons of formulations and intended uses of the KaVo devices to legally marketed predicates and to the IDENTIFICATION of porcelain powders in 21 CFR 872.6660."

    Therefore, I cannot provide the requested information regarding acceptance criteria and performance data from a study for this specific device. The device's approval was based on demonstrating substantial equivalence to predicate devices, focusing on formulation and intended use, rather than a clinical performance study with specific metrics.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1