Device Classification Name |
aligner, sequential
|
510(k) Number |
K191774 |
Device Name |
SmileAlign Orthodontic Aligner System |
Applicant |
3D Global Biotech Inc. |
21F.-1, No.99, Sec. 1, Xintai 5th Rd., Xizhi Dist., |
New Taipei City 221,
TW
|
|
Applicant Contact |
Keng-Liang Ou |
Correspondent |
DuoCare, LLC |
370 W Grand Blvd #110, |
Corona,
CA
92882
|
|
Correspondent Contact |
Diana Lam |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 07/02/2019 |
Decision Date | 09/30/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|