LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K053114
    Device Name
    SILVERFIL
    Manufacturer
    DUNIA PERWIRA MANUFACTURING SDN. BHD.
    Date Cleared
    2005-11-15

    (8 days)

    Product Code
    EJJ
    Regulation Number
    872.3070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUNIA PERWIRA MANUFACTURING SDN. BHD.

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

    Silverfil amalgam is used by dental professionals to fill tooth cavities. It is used in the same way as other amalgams used in the world today. Its usage and handling techniques are the same as other amalgams.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for a dental amalgam alloy. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is primarily focused on the declaration of "substantial equivalence" to a predicate device, which is a regulatory pathway for certain medical devices.

    Therefore, I cannot provide the requested information as it is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1