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510(k) Data Aggregation

    K Number
    K254163

    Validate with FDA (Live)

    Device Name
    VarioSurg 4
    Manufacturer
    Nakanishi, Inc.
    Date Cleared
    2025-12-23

    (1 days)

    Product Code
    DZI
    Regulation Number
    872.4120
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K242432,K233117,K073678
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VarioSurg 4 is intended for bone cutting in oral surgery, scaling and root planing, and retrograde preparation of root canals.

    Device Description

    VarioSurg 4 consists of the control unit, the foot control, the ultrasonic handpiece, and accessories. The control unit generates an ultrasonic electrical signal and is used to control functions such as power output, irrigation flow, and operation mode. The foot control allows for "hands-free" control of the irrigation flow, program selection, and turning the ultrasound on/off. The ultrasonic handpiece (VS4-LED-HPSC) incorporates a piezoelectric transducer that converts the electrical signal into mechanical vibrations and is also equipped with LED illumination.

    VarioSurg 4 is intended for use in dental periodontal therapy and dental oral surgery for procedures such as bone cutting, root canal preparation, and the removal of deposits from teeth. The device is designed to be used with the ultrasonic handpiece, which drives various tips vibrating at an ultrasonic frequency to perform cutting, removal, and incision of hard and soft tissues within the oral cavity.

    A feature of this product is its Bluetooth connectivity with the foot control and its ability to connect to the Surgic Pro2 (K233117) system. When connected, a single foot control can operate both systems. The product is supplied non-sterile. The handpiece and tips are to be cleaned and sterilized at a medical facility before use and are intended for repeated use.

    AI/ML Overview

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