Device Classification Name |
aligner, sequential
|
510(k) Number |
K192596 |
Device Name |
ULab Systems Dental Aligner Kit |
Applicant |
uLab Systems, Inc. |
6 Lagoon Drive, Suite 180 |
Redwood City,
CA
94065
|
|
Applicant Contact |
Charlie Wen |
Correspondent |
Sylvia Erickson Consulting |
157 Ruby Avenue |
San Carlos,
CA
94070
|
|
Correspondent Contact |
Sylvia Erickson |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 09/20/2019 |
Decision Date | 02/11/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|