Device Classification Name |
aligner, sequential
|
510(k) Number |
K202857 |
Device Name |
ClearPath Aligner |
Applicant |
ClearPath Orthodontics Ltd |
6-N, Main Boulevard |
Johar Town,
PK
54000
|
|
Applicant Contact |
Waqas Wahab |
Correspondent |
Qserve Group US, Inc. |
7949 Beaumont Green East Drive |
Indianapolis,
IN
46250
|
|
Correspondent Contact |
Patsy J Trisler |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 09/28/2020 |
Decision Date | 01/05/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|