Definition: Intended For Use In Orthodontic Treatment. The Device Is Affixed To A Tooth So That Pressure Can Be Exerted On The Teeth.
| Device Type ID | 1352 |
| Device Name | Bracket, Metal, Orthodontic, Reprocessed |
| Regulation Description | Orthodontic Appliance And Accessories. |
| 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 | 872.5410 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NQS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 1352 |
| Device | Bracket, Metal, Orthodontic, Reprocessed |
| Product Code | NQS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthodontic Appliance And Accessories. |
| CFR Regulation Number | 872.5410 [🔎] |