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510(k) Data Aggregation
K Number
K182947Device Name
Dental Pain Eraser
Manufacturer
Date Cleared
2019-03-26
(154 days)
Product Code
Regulation Number
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Applicant Name (Manufacturer) :
Synapse Dental, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dental Pain Eraser DPE-C300 is intended to provide temporary dental anesthesia (pain relief) and is indicated for use before, during, or after dental and orthodontic procedures, and other sources of oral pain. It is intended for use by dental/orthodontic professionals for the alleviation of oral pain.
Device Description
The Dental Pain Eraser 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 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 and 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.
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