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510(k) Data Aggregation
K Number
K172978Device Name
SurgeoBite
Manufacturer
Surgovations LLC
Date Cleared
2017-12-22
(86 days)
Product Code
JXL
Regulation Number
882.5070Why did this record match?
Applicant Name (Manufacturer) :
Surgovations LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SurgeoBite® device is single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy, spontaneous seizures, neuromonitoring stimulation, and any circumstances requiring protection of the teeth, lips, tongue, and buccal mucosa.
Device Description
The SurgeoBite is designed to be an easy to use and safe device for use in the patient's mouth. The shape of the device allows for easy positioning into the mouth and provides a biting surface between the teeth making sure that the tongue and cheeks are not between the biting surfaces. During seizures induced by electroconvulsive therapy, neuromonitoring stimulation, spontaneous seizures, and circumstances requiring protection, the jaw muscles can contract and cause potential damage to the teeth and mouth tissues. By placing the oral protector in the patient's mouth, it will provide protection of the teeth, lips, tongue, and buccal mucosa. The SurgeoBite is sold nonsterile, single use, and is discarded after use.
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