Device Classification Name |
Aligner, Sequential
|
510(k) Number |
K203737 |
Device Name |
Spark Clear Aligner System |
Applicant |
Ormco Corporation |
200 S Kraemer Blvd |
Brea,
CA
92821
|
|
Applicant Contact |
Frank Ray |
Correspondent |
Ormco Corporation |
200 S Kraemer Blvd |
Brea,
CA
92821
|
|
Correspondent Contact |
Frank Ray |
Regulation Number | 872.5470
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/22/2020 |
Decision Date | 03/22/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|