LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K071447
    Device Name
    VARIOS 75
    Manufacturer
    NAKANISHI, INC.
    Date Cleared
    2008-04-18

    (330 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VARIOS 75

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device, Varios 75, 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 Intervention / Finishing / Trimming / Polishing / Caries of Dentin), Prosthetics (Condensation / Loosening / Plugging)
    Device Description

    Varios 75, an electric ultrasonic scaler

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a medical device (Varios 75, an ultrasonic scaler). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot provide the requested information based on this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1