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510(k) Data Aggregation

    K Number
    K122501
    Device Name
    AEI DR. TERAUCHI ULTRASONIC TIPS
    Manufacturer
    AMERICAN EAGLE INSTRUMENTS, INC.
    Date Cleared
    2013-03-29

    (225 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN EAGLE INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AEI Dr. Terauchi Ultrasonic Tips are intended for use by dental professionals for endodontic root preparation procedures. The Ultrasonic Tips can remove soft and hard tissue from a narrow dentinal structure in order to make space for permanent filling material in the canal. They can also assist in the removal of separated instruments or other intra-canal blockages.
    Device Description
    The AEI Ultrasonic Tips are an accessory to a Piezo ultrasonic hand piece and unit. These external power supplies are not part of the device submitted for application with the 510(k) submission. The Ultrasonic Tips with a concave spoon shape or straight tip are very small and will not cut significant amounts of dentin during use. The AEI Ultrasonic Tips will be available in M3x0.6 thread with 5 different types of tip design to facilitate reaching specific angles and directions in the root of the tooth.
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    K Number
    K042972
    Device Name
    XP TECHNOLOGY ULTRASONIC SCALER
    Manufacturer
    AMERICAN EAGLE INSTRUMENTS, INC.
    Date Cleared
    2005-03-18

    (141 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN EAGLE INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An ultrasonic scaling system is used by dental professionals as a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth. This device is contraindicated for children and adults with synthetic teeth. This device should not be used on patients or by users who have a pacemaker.
    Device Description
    XP TECHNOLOGY Ultrasonic Scaler
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