| Proprietary Name: |
3Shape Ortho System Mouthguard |
| Classification Name: |
MOUTHGUARD, PRESCRIPTION |
| Product Code: |
MQC |
| Device Class: |
Unclassified |
| Registered Establishment Name: |
3Shape A/S
|
| Registered Establishment Number: |
3005940400
|
| Premarket Submission Number: |
K161884 |
| Owner/Operator: |
3Shape A/S |
| Owner/Operator Number: |
10023901
|
| Establishment Operations: |
Specification Developer
|
|
|