BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Sonendo Gentle Wave System

    K Number: K153157 · Decision Jan 29, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    194
    Applicant Total
    9
    Review Days
    88

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    Basic Information

    Device Name
    Sonendo Gentle Wave System
    K Number
    K153157
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.4850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sonendo, Inc.
    Date Received
    November 2, 2015
    Decision Date
    January 29, 2016
    Product Code
    ELC
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ELC Scaler, Ultrasonic

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    Other Clearances by Sonendo, Inc.

    K Number Device Name
    K211995 Sonendo Filling Material 5C
    K203302 GentleWave X
    K190359 Sonendo GentleWave System
    K181922 Sonendo Material A
    K160905 Sonendo GentleWave System
    K143448 Sonendo GentleWave System
    K133752 SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT
    K130025 SONENDO ENDOTHERAPY SYSTEM