Device Classification Name |
aligner, sequential
|
510(k) Number |
K220726 |
Device Name |
K Clear |
Applicant |
K Line Europe GmbH |
Niederrheinstraße 16 |
Dusseldorf,
DE
40474
|
|
Applicant Contact |
Sherif Kandil |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 03/14/2022 |
Decision Date | 03/16/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|