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510(k) Data Aggregation

    K Number
    K103346
    Device Name
    DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY
    Manufacturer
    SHERPA KOREA
    Date Cleared
    2011-02-11

    (88 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHERPA KOREA

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

    Delikit is an addition-cure vinyl polysiloxane dental that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

    Device Description

    Delikit is an addition-cure vinyl polysiloxane dental

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) summary for the "Delikit" Impression Material does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.

    The document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It does not include details on performance studies, sample sizes, ground truth establishment, or expert involvement as typically found in a clinical or performance study summary.

    Therefore, I cannot provide the requested table and information based on this document.

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