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510(k) Data Aggregation

    K Number
    K062130
    Device Name
    MEISINGER BENEX, MODEL BE001
    Manufacturer
    HAGER & MEISINGER GMBH
    Date Cleared
    2007-04-16

    (264 days)

    Product Code
    EMG
    Regulation Number
    872.4565
    Why did this record match?
    Product Code :

    EMG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Meisinger Benex Tooth Extraction device is to be used to extract teeth and tooth roots when traditional forceps extraction is not possible or when tooth luxation trauma to the alveolar bone is to be kept to a minimum.
    Device Description
    Not Found
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    K Number
    K060691
    Device Name
    EASY X-TRAC SYSTEM
    Manufacturer
    A. TITAN INSTRUMENTS, INC.
    Date Cleared
    2006-06-12

    (89 days)

    Product Code
    EMG
    Regulation Number
    872.4565
    Why did this record match?
    Product Code :

    EMG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Easy X-Trac System is to be used to extract single and double rooted teeth as an implemented pre-implantological method by professionals only. The Easy X-Trac is only to be used for extraction of single and double rooted teeth by I he Lasy X-Trac is only. The system may be used to extract broken-down teeth with ucular professionals only . Its extract vertically or horizontally fractured teeth.
    Device Description
    The Easy X-Trac System is a tooth extraction system that is used to extract single- and double-rooted teeth. Use of this system may minimize bone loss, reduce damage to soft tissue and preserve the alveolous prior to immediate or delayed implant placement more than with regular extraction instruments such as extraction forceps and root elevators. The Easy X-Trac System uses a complete vertical lifting motion without rotary- or tliting movements to lift a tooth out of the socket. By using this technique the user might have a greater chance of preserving the socket and preventing damage to hard soft tissues such as lamella and buccal and labial plates.
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