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510(k) Data Aggregation

    K Number
    K252223
    Date Cleared
    2025-10-16

    (92 days)

    Product Code
    Regulation Number
    872.4200
    Panel
    Dental
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Alpha Endo Handpiece is a cordless motor handpiece with torque control used for driving files in both reciprocating and rotation mode during the preparation stage of root canal therapy.

    Device Description

    The Alpha Endo Handpiece is a medical electrical device that provides the driving force required for surgical instruments used in root canal surgery to enlarge and shape the root canal during root canal surgery. The Alpha Endo Handpiece mainly uses a variable speed gear plate to turn the high speed of the motor into the low speed required for root canal preparation surgery, while obtaining a larger cutting torque, and then further increases or reduces the speed and torque within this range through the speed regulating circuit, making root canal preparation efficient and safe. Speed and maximum torque are selectable and are always controlled by a torque sensor with an automatic protection mode to prevent the file needle from breaking.

    AI/ML Overview

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