Device Classification Name |
aligner, sequential
|
510(k) Number |
K210320 |
Device Name |
ClearCorrect System |
Applicant |
ClearCorrect LLC |
21 Cypress Boulevard, Suite 1010 |
Round Rock,
TX
78665
|
|
Applicant Contact |
Christopher Klaczyk |
Correspondent |
ClearCorrect LLC |
21 Cypress Boulevard, Suite 1010 |
Round Rock,
TX
78665
|
|
Correspondent Contact |
Christopher Klaczyk |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 02/04/2021 |
Decision Date | 08/06/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|