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510(k) Data Aggregation

    K Number
    K153157
    Device Name
    Sonendo Gentle Wave System
    Manufacturer
    SONENDO, INC.
    Date Cleared
    2016-01-29

    (88 days)

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

    Sonendo Gentle Wave System

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

    The Sonendo GentleWave™ System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave™ Molar HandPiece, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo GentleWave™ Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the Sonendo GentleWave™ System, confirming its substantial equivalence to a predicate device and outlining its indications for use. It does not include data from performance studies.

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