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510(k) Data Aggregation

    K Number
    K192429
    Device Name
    Dental Pain Eraser
    Manufacturer
    Synapse Dental
    Date Cleared
    2020-01-14

    (131 days)

    Product Code
    LWM
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K182947
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Dental Pain Eraser DPE-T300 is intended to provide temporary dental anesthesia (pain relief). It is intended for prescriptive use only for the alleviation of oral pain for use by pediatric (10 years of age) and adult patients for treatment at home. Pediatric patients 10 through 12 years of age must be supervised by an adult.

    Device Description

    The Dental Pain Eraser DPE-T300 is a non-invasive electrical stimulation device that is used to numb the nerve pain associated with orthodontic procedures and to dull the pain of canker sores often developed inside the mouths of patients wearing braces or retainers. This method of treatment is referred to as Transcutaneous Electrical Nerve Stimulation (TENS). The Dental Pain Eraser DPE-T300 has a shape and size similar to a common toothbrush, except that in place of the bristles are two metal electrodes. In operation, the device is turned on for 30 seconds to 10 minutes, the two electrodes are rubbed gently up and down the gums above the patient's aching tooth or on the intact skin around the canker sore. Current flowing between the electrodes through the gum anesthetizes the nearby nerves thus alleviating pain.

    AI/ML Overview

    The provided text describes the Synapse Dental Pain Eraser DPE-T300, a device intended for temporary dental anesthesia (pain relief) for at-home use. The document focuses on demonstrating its substantial equivalence to a predicate device (Dental Pain Eraser DPE-C300) through nonclinical and usability testing, rather than an effectiveness study proving specific acceptance criteria in terms of pain relief metrics.

    Therefore, the acceptance criteria are primarily related to safety, essential performance, and usability for at-home use, ensuring it does not raise new issues of safety or effectiveness compared to the predicate.

    Here's an analysis based on the provided information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Given that this is a 510(k) submission focused on substantial equivalence to a predicate device, the "acceptance criteria" are implied by the standards and testing performed to demonstrate that the new device (DPE-T300) is as safe and effective as the predicate (DPE-C300), particularly for a change in use environment (from professional facility to home use).

    Acceptance Criteria (Implied)Reported Device Performance (DPE-T300)
    Safety and Essential Performance (Non-Clinical)
    Compliance with IEC 60601-1-11 (Home Healthcare Environment)Compliant. Synapse performed safety testing in accordance with IEC 60601-1-11, Edition 2.0, 2015-01, demonstrating basic safety and essential performance for lay or trained healthcare personnel in the home healthcare environment.
    Ingress Protection (IP) Rating appropriate for home useIP24. Tested in accordance with IEC 60529, Edition 2.2, 2013-08. This rating is considered appropriate for home use and does not raise different safety/effectiveness questions compared to the predicate's IP21 rating.
    Electrical Safety (Patient Leakage Current, Output Specs)Compliant. Matches predicate (DC ~0 µA AC
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