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510(k) Data Aggregation

    K Number
    K062731
    Device Name
    ULTRASONIC SCALER, VARIOS 560
    Manufacturer
    NAKANISHI, INC.
    Date Cleared
    2007-05-01

    (230 days)

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

    This device, Varios 560, an electric ultrasonic scaler, is intended for use with an appropriate tip for following use.

    • Scaling, Perio, Implant Maintenance, Endodontic, Retrograde Endo, Restorative (for Minimal Scameg, Forto, Inprintin Mailier, Balishing / Caries of Dentin), Prosthetics (Condensation / Loosening / Plugging)
    Device Description

    electric ultrasonic scaler

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for an ultrasonic scaler. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.

    Therefore, I cannot provide the requested information based on the provided text.

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