Device Classification Name |
Aligner, Sequential
|
510(k) Number |
K210613 |
Device Name |
HIT Clear Aligner |
Applicant |
CDB Corporation |
9201 Industrial Park Boulevard |
Leland,
NC
28451
|
|
Applicant Contact |
Leah M Lehman |
Correspondent |
CDB Corporation |
9201 Industrial Boulevard, NE |
Leland,
NC
28451
|
|
Correspondent Contact |
Leah M Lehman |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 03/01/2021 |
Decision Date | 06/04/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|