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

    Dental Pain Eraser

    K Number: K182947 · Decision Mar 26, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    154

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    Basic Information

    Device Name
    Dental Pain Eraser
    K Number
    K182947
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synapse Dental, LLC
    Date Received
    October 23, 2018
    Decision Date
    March 26, 2019
    Product Code
    LWM
    Advisory Committee
    Unknown
    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
    LWM Device, Electrical Dental Anesthesia

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