Device Classification Name |
Unit, Operative Dental
|
510(k) Number |
K183347 |
Device Name |
K3 |
Applicant |
Osstem Implant Co., Ltd. |
1st Floor, B-dong, 135 Gasan Digital 2-ro, Geumcheon-gu |
Seoul,
KR
08504
|
|
Applicant Contact |
Hyeri Han |
Correspondent |
Hiossen Inc. |
85 Ben Fairless Dr |
Pennsylvania,
PA
19030
|
|
Correspondent Contact |
Peter Lee |
Regulation Number | 872.6640
|
Classification Product Code |
|
Date Received | 12/03/2018 |
Decision Date | 09/04/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|