LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060507
    Device Name
    VALPLAST YAMAHACHI TEETH
    Manufacturer
    VALPLAST INTL. CORP.
    Date Cleared
    2006-04-07

    (39 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Applicant Name (Manufacturer) :

    VALPLAST INTL. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Valplast International Corporation Yamahachi Teeth are prefabricated, preformed plastic teeth that are intended for use as teeth in removable dentures.
    Device Description
    The Yamahachi Teeth are anterior and posterior teeth that are intended to be used in removable dentures only. They are made up of three synthetic polymers including polymethlymethacrylate, polymethylmethacrylate-SiO2, and a composite resin urethane dimethacrylate-polymethylmethacrylate - SiO2. The Yamahachi Teeth are used in conjunction with a denture-base resin for construction of removable full and partial dentures. The teeth are intended to be used by dental professionals such as dentists and dental technicians. The Yamahachi line of teeth include various sizes, shapes, and shades of anterior and posterior preformed plastic teeth
    Ask a Question

    Page 1 of 1