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510(k) Data Aggregation

    K Number
    K980968
    Device Name
    LONE STAR IMPRESSION SYSTEMS
    Manufacturer
    LONE STAR TECHNOLOGIES
    Date Cleared
    1998-06-09

    (85 days)

    Product Code
    ELW, EZW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    LONE STAR TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in taking the final Impression of prepared teeth in adult or deciduous teeth when the dentist has determined that a crown or a bridge is needed. The dentist examines the patient and determines the need for a crown or bridge. They then prepare the teeth or tooth in their usual manner. The two component impression material is then mixed manually or automatically and placed into an impression tray of the dentists' choosing. The material is then placed in the mouth and allowed to set, approx. 4 minutes, resulting in an impression of the prepared teeth. The resulting impression is then disinfected and a model is poured from this impression for use by the dentist or dental lab in preparation of the crown or bridge that is to be constructed.
    Device Description
    Impression Material
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    K Number
    K981234
    Device Name
    FLARE,FILE, FILL
    Manufacturer
    LONE STAR TECHNOLOGIES
    Date Cleared
    1998-06-05

    (62 days)

    Product Code
    EJB
    Regulation Number
    872.4565
    Why did this record match?
    Applicant Name (Manufacturer) :

    LONE STAR TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in the preparation of root canals prior to the final filling of the root canals in adult or deciduous teeth. The Dentist or Endodontist examines the patient to determine if the method of treatment is to be the removal of the root canal for the appropriate reasons. After opening the tooth with the access bur the first part of the root canal is exposed to the point where the canals tend to branch out about one third of the way. The Dentist then follows his standard procedure of locating the Apex and removal of the nerve and decayed matter from the canal using the Flare--File -- Fill procedures.
    Device Description
    Not Found
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