Device Classification Name |
aligner, sequential
|
510(k) Number |
K192846 |
Device Name |
Argen Clear Aligner, Argen Clear Aligner Premium |
Applicant |
Argen Corporation |
5855 Oberlin Drive |
San Diego,
CA
92121
|
|
Applicant Contact |
Paul Cascone |
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 | 10/03/2019 |
Decision Date | 02/10/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|