SOMATICS MOUTH GUARD (BITE BLOCK)
Device Facts
| Record ID | K864181 |
|---|---|
| Device Name | SOMATICS MOUTH GUARD (BITE BLOCK) |
| Applicant | Somatics, Inc. |
| Product Code | JXL · Neurology |
| Decision Date | Nov 3, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5070 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions.
