Device Classification Name |
Orthodontic Software
|
510(k) Number |
K191911 |
Device Name |
3Shape Splint Design |
Applicant |
3Shape A/S |
Copenhagen,
DK
1060
|
|
Applicant Contact |
Shreyosi Chakraborty |
Correspondent |
3Shape A/S |
Copenhagen,
DK
1060
|
|
Correspondent Contact |
Shreyosi Chakraborty |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 07/17/2019 |
Decision Date | 11/27/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|