Device Classification Name |
Aligner, Sequential
|
510(k) Number |
K213297 |
Device Name |
Redline |
Applicant |
Johns Dental Laboratories |
423 S. 13th ST |
Terre Haute,
IN
47807
|
|
Applicant Contact |
Marni Buis |
Correspondent |
Evo820, LLC |
1 Bay Street |
Rancho Mission Viejo,
CA
92694
|
|
Correspondent Contact |
Na Zhang |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 10/01/2021 |
Decision Date | 02/09/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|