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510(k) Data Aggregation

    K Number
    K240183
    Device Name
    Star E900 Handpiece Series
    Manufacturer
    DentalEZ, Inc., StarDental Division
    Date Cleared
    2024-09-19

    (240 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    DentalEZ, Inc., StarDental Division

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Star E900 Handpiece Series are intended to be used for general dentistry by trained dental professionals. The intended use of the respective handpieces is dependent on the gear ratio. Star E900 1:5 Handpiece: the removal of decayed matter, cavity and crown preparations, the removal of fillings and surface finishing of tooth and restoration surfaces. Star E900 1:1 Handpiece: Cavity preparations, caries excavation, endodontic applications, processing of tooth and restoration surfaces. Star E900 5:1 Handpiece: Cavity preparations, caries excavation, endodontic applications, processing of tooth and restoration surfaces. Star E900 1:1 Straight Handpiece: prophylaxis treatment, crown preparations, polishing of tooth and restoration surfaces
    Device Description
    The Star E900 Handpiece Series are reusable contra-angle handpieces, driven by an ISO 3964 compliant electric micro-motor or air driven motor, that are intended for use by trained dental professionals in the field of general dentistry. The Star E900 1:5, 1:1 and 5:1 handpieces are designed for general applications to prepare dental cavities for restoration. The Star E900 1:1 Straight Handpiece is designed for prophylaxis treatment, crown preparations, polishing finishing of tooth and restoration surfaces. The Star E900 Handpiece Series feature an ISO 3964 compliant handpiece coupling connecting them to an electric micro-motor controlled by an electric control unit or air driven motor connected to a dental delivery unit. The control unit or delivery unit supplies energy to the handpiece which powers the gears within the handpieces. Depending on the applications, the handpieces have a maximum drive speed of 8,000 to 200,000 RPM's. These handpieces are ergonomically shaped and have glass rod fiberoptics to illuminate the oral cavity during procedures. In addition, the handpieces have multi-port water spray. The exception to the fiber optics and water spray features is the Star E900 1:1 Straight Handpiece. This handpiece does not contain any fiberoptics nor does it have water spray capabilities. All the handpieces in the Star E900 Handpiece series are composed of stainless steel and PEEK. They can be autoclaved. The Star E900 Handpieces use only burs with hardened, tempered steel shanks or carbide shanks which are ISO 1797 compliant. All handpieces in this series incorporate RFID (radio frequency identification) technology. This passive RFID tag does not have a built-in energy source. The RFID tag will allow the practitioner to track the device within the office only if the practitioner has a separate reader. The RFID reader will enable the practitioner to track such things as usage and maintenance. The handpieces, with the exception of the Star E900 1:1 Straight Handpiece, incorporate a temperature sensor to be used in the service of the device, by trained service personnel, to access excessive heat in the handpiece, indicative of mechanical failure. This feature is not accessible to the practitioner.
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