Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K233194 |
Device Name |
TS Abutment System |
Applicant |
Osstem Implant Co., Ltd. |
66-16, Bansong-ro 513beon-gil, Haeundae-gu |
Busan,
KR
48002
|
|
Applicant Contact |
Seungju Kang |
Correspondent |
HioSSEN Inc. |
85 Ben Fairless Dr. |
Fariless Hills,
PA
19030
|
|
Correspondent Contact |
Peter Lee |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 09/28/2023 |
Decision Date | 02/20/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|