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510(k) Data Aggregation

    K Number
    K251689
    Manufacturer
    Date Cleared
    2025-09-19

    (109 days)

    Product Code
    Regulation Number
    872.4850
    Panel
    Dental
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device, VARIOS 170 LUX SCALER SYSTEM / VARIOS 170 SCALER SYSTEM, an electronic ultrasonic scaler, is intended for use with an appropriate tip for following use: Scaling, Perio, Implant Maintenance, Endodontic, Retrograde Endo, Restorative (for Minimal Intervention/Finishing/Trimming/Polishing/Caries of Dentin), Prosthetics (Condensation/Loosening/Plugging).

    Device Description

    This device, the VARIOS 170 LUX SCALER SYSTEM / VARIOS 170 SCALER SYSTEM is an ultrasonic scaler system intended for use with an appropriate tip for the following use: Scaling, Perio, Implant Maintenance, Endodontic, Retrograde Endo, Restorative (for Minimal Intervention/Finishing/Trimming/Polishing/Caries of Dentin), Prosthetics (Condensation/Loosening/Plugging). The device consists of the VA170 Built-in Module, Ultrasonic Handpiece, Handpiece Cord, and accessories. Components and accessories are included with each series set in accordance with the client's specific needs and requirements. The device converts an ultrasonic-frequency electrical signal into mechanical vibrations using a piezoelectric ceramic, which then vibrates the tip at ultrasonic frequencies. The Tip attached at the distal end of the transducer vibrates at ultrasonic frequencies and enables the device to achieve the intended use.

    AI/ML Overview

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