Device Classification Name |
aligner, sequential
|
510(k) Number |
K191838 |
Device Name |
Clearform Aligners |
Applicant |
Motor City Lab Works |
2200 Holland Street |
Birmingham,
MI
48009
|
|
Applicant Contact |
Christina Groth |
Correspondent |
Aclivi, LLC |
6455 Farley Road |
Pinckney,
MI
48169
|
|
Correspondent Contact |
Chris Brown |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 07/09/2019 |
Decision Date | 03/20/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|