Somatics Mouth Guard (Bite Block)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K864181 FDA 510(k)
- FDA Product Code
- JXL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5070 FDA 510(k)
- Regulation Number
- 882.5070 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Somatics Mouth Guard (Bite Block) is a protective oral device classified as a bite block, designed to prevent injury to the tongue and teeth during convulsive events. It is intended to be inserted into the mouth to reduce the risk of dental trauma or tongue biting during seizures or similar neurological conditions.
This reusable device is autoclavable and supplied in two sizes to accommodate different patient anatomies. It is regulated under FDA 510(k) clearance (K864181) and falls under classification II (Regulation 882.5070), with a medical specialty designation in neurology. Sterilization is achieved through autoclaving, and it is intended for single-patient reuse before reprocessing.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Somatics, LLC - Catalog - MouthGuard™, SOMATICS MOUTH GUARD (BITE BLOCK) 510(k) K864181 - FDA.report, SOMATICS MOUTH GUARD (BITE BLOCK) - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K864181 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Somatics, Inc.
Sources (1)
- FDA 510(k) K864181 24 fields · synced Sep 19, 2026