| Device Type ID | 1098 |
| Device Name | Headgear, Extraoral, Orthodontic |
| Regulation Description | Extraoral Orthodontic Headgear. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.5500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DZB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |