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510(k) Data Aggregation

    K Number
    K152826
    Device Name
    NoCord
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    2016-05-27

    (241 days)

    Product Code
    ELW,MVL
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NoCord

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

    NoCord with astringent is a low viscosity vinyl polysiloxane impression material which is indicated for use as the wash material when the tray/wash technique is performed for indirect dental restorations. When applied as the wash material, NoCord

    1. Retracts the gingival tissue to expose the sub-gingival margin
    2. Controls gingival bleeding
    3. Reproduces the structure of a patient's teeth and gums
    Device Description

    NoCord is a low viscosity vinyl polysiloxane impression material.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a dental impression material without any information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the information requested in your prompt.

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