|
|
| Device |
orthodontic software |
| 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 only. |
| Product Code | PNN |
| Regulation Number |
872.5470
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| ARCHFORM, INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BRIUS TECHNOLOGIES INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CDB CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CHOICE BIOTECH INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CLEARADVANCE, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CLEVALIGNER LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DIORCO CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| LAON MEDI INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MECHANODONTICS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ORTHOSELECT, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| PROGRESSIVE ALIGNERS INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| RAY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHANGHAI EA MEDICAL INSTRUMENTS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SOFTSMILE, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SOFTWARE NEMOTEC S.L. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| SWIFT HEALTH SYSTEMS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| TROPHY |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ULAB SYSTEMS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
|
| MDR Year |
MDR Reports |
MDR Events |
| 2024 |
1 |
1 |
|
|
|
|
