|
|
| Device |
orthodontic software |
| Regulation Description |
Orthodontic plastic bracket. |
| 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 |
|---|
| AMV CONSULTING, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ARCHFORM, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BRIUS TECHNOLOGIES, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CDB CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CELEBRACE |
| |
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
|
2
|
| 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
|
|
1. K203442 Inbrace Orthodontic System
|
| TROPHY |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ULAB SYSTEMS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
|
| MDR Year |
MDR Reports |
MDR Events |
| 2024 |
1 |
1 |
|
|
|
|
