Device Classification Name |
Aligner, Sequential
|
510(k) Number |
K203339 |
Device Name |
NEOLab Clear Aligners |
Applicant |
New England Ortho Lab, Inc |
3 Riverside Drive |
Andover,
MA
01810
|
|
Applicant Contact |
Christian Saurman |
Correspondent |
New England Ortho Lab, Inc |
3 Riverside Drive |
Andover,
MA
01810
|
|
Correspondent Contact |
Olivia Channon |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 11/12/2020 |
Decision Date | 01/06/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|