| Device |
bracket, metal, orthodontic, reprocessed |
| Regulation Description |
Orthodontic appliance and accessories. |
| Definition |
Intended for use in orthodontic treatment.The device is affixed to a tooth so that pressure can be exerted on the teeth. |
| Regulation Medical Specialty |
Dental |
| Review Panel |
Dental |
| Product Code | NQS |
| Submission Type |
510(k)
|
| Regulation Number |
872.5410
|
| Device Class |
1
|
| GMP Exempt? |
No
|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
|
|