Definition: The Device Is Software That Is To Be Used For The Diagnosis And Treatment Planning Of Orthodontic Patients And Conditions. It May Include Orthodontic Output Devices Used For The Treatment Of Orthodontics. The Device Is Intended For Prescription Use O
| Device Type ID | 1385 |
| Device Name | Orthodontic Software |
| Physical State | Software Which May Produce An Orthodontic Appliance |
| Technical Method | May Use Software, Scanning Equipment, CAD/CAM, And Printing Machines For The Fabrication Of Orthodontic Appliances |
| Target Area | Intraoral |
| Regulation Description | Orthodontic Plastic Bracket. |
| 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 | 872.5470 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PNN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1385 |
| Device | Orthodontic Software |
| Product Code | PNN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Orthodontic Plastic Bracket. |
| CFR Regulation Number | 872.5470 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
3SHAPE A/S | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
GUIDEMIA TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ULAB SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |