Device Classification Name |
Aligner, Sequential
|
510(k) Number |
K210763 |
Device Name |
Inman Digital Clear Aligners |
Applicant |
Inman Orthodontic Laboratories, Inc. |
3953 NW 126th Avenue |
Coral Springs,
FL
33065
|
|
Applicant Contact |
Donal P. Inman |
Correspondent |
Trisler Consulting |
7949 Beaumont Green East Drive |
Indianapolis,
IN
46250
|
|
Correspondent Contact |
Patsy J. Trisler |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 03/15/2021 |
Decision Date | 09/29/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|