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510(k) Data Aggregation

    K Number
    K053018
    Device Name
    POLY SILOXANE IMPRESSION MATERIAL
    Manufacturer
    MILLENNIUM DENTAL INTERNATIONAL, INC.
    Date Cleared
    2005-11-08

    (13 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) :

    MILLENNIUM DENTAL INTERNATIONAL, INC.

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

    Device intended to be placed intraorally or on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

    Device Description

    Multiple (POLY SILOXANE IMPRESSION MATERIAL)

    AI/ML Overview

    I am sorry but this document does not contain the information you are looking for. This document is a letter from the FDA to Millennium Dental International, Incorporated regarding their 510(k) premarket notification for a POLY Siloxane Impression Material. It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. The document does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

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