PREMIER PROMAX BITE GUARD
Device Facts
| Record ID | K941856 |
|---|---|
| Device Name | PREMIER PROMAX BITE GUARD |
| Applicant | Premier Dental Products Co. |
| Product Code | JXL · Neurology |
| Decision Date | Apr 5, 1995 |
| 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.
