Device Classification Name |
orthodontic software
|
510(k) Number |
K171295 |
Device Name |
ULab Systems Treatment Planning Software |
Applicant |
ULab Systems, Inc. |
101 Jefferson Drive, Suite 212A |
Menlo Park,
CA
95025
|
|
Applicant Contact |
Charlie Wen |
Correspondent |
ULab Systems, Inc. |
101 Jefferson Drive, Suite 212A |
Menlo Park,
CA
95025
|
|
Correspondent Contact |
Charlie Wen |
Regulation Number | 872.5470
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/02/2017 |
Decision Date | 01/09/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|