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510(k) Data Aggregation

    K Number
    K260773

    Validate with FDA (Live)

    Device Name
    Varios Combi Pro2
    Manufacturer
    Nakanishi, Inc.
    Date Cleared
    2026-03-10

    (1 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K190124
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The dental device is intended for the following application(s):
    [Tooth Polishing System]
    Removal of supragingival and subgingival accretions and deposits, and accretions and deposits on prostheses (including implants).
    [Ultrasonic Scalers]
    Removal of accretions and deposits from the surface of teeth and dental restorations (fillings and prostheses), finishing (preparation and adjustment/polishing), removal and cleaning of infected dental tissues, and root canal preparation.

    Device Description

    Varios Combi Pro2 consists of the control unit, the foot control, the ultrasonic handpiece, the powder handpiece, and accessories. The control unit integrates two operational systems: an ultrasonic generator for scaling and a powder supply system for air polishing. It is used to control functions such as power output, irrigation flow, powder/air mixture, and operation mode. The foot control allows for "hands-free" control of the spray, power output, and turning the device on/off. The ultrasonic handpiece (VA2-LUX-HP Ti) incorporates a piezoelectric transducer that converts the electrical signal into mechanical vibrations and is also equipped with LED illumination. The powder handpiece directs a mixture of powder, air, and water to the tooth surface for cleaning.

    Varios Combi Pro2 is intended for use in dental periodontal therapy and tooth surface cleaning for procedures such as scaling, root canal preparation, and the removal of stains and plaque. The device is designed to be used with the ultrasonic handpiece for removing hard deposits and with the powder handpiece for removing supragingival and subgingival accretions, deposits, and stains from teeth and prostheses.

    A feature of this product is the integration of ultrasonic scaling and powder polishing capabilities into a single unit, allowing for efficient workflow in oral hygiene management. The system automatically detects the attached handpiece (Prophylaxis or Perio) to select the appropriate powder operating mode. It also features Bluetooth connectivity with the foot control for wireless operation.

    The product is supplied non-sterile. The handpieces, tips, and nozzles are to be cleaned and sterilized at a medical facility before use and are intended for repeated use.

    AI/ML Overview

    N/A

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