Device Classification Name |
Aligner, Sequential
|
510(k) Number |
K192244 |
Device Name |
Arcad SmileStudio and Aligner System |
Applicant |
ArcadLab |
1860 Old Okeechobee Road, Suite 402 |
West Palm Beach,
FL
33409
|
|
Applicant Contact |
Emerson Cano |
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 |
|
Subsequent Product Code |
|
Date Received | 08/19/2019 |
Decision Date | 05/11/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|