| Device Type ID | 3735 |
| Device Name | Block, Bite |
| Regulation Description | Bite Block. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Psychiatry Branch (NSDP) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5070 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JXL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3735 |
| Device | Block, Bite |
| Product Code | JXL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bite Block. |
| CFR Regulation Number | 882.5070 [🔎] |
| Device Problems | |
|---|---|
Break | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Appropriate Term/Code Not Available | 2 |
Material Separation | 1 |
| Total Device Problems | 7 |