Device Classification Name |
screw, fixation, intraosseous
|
510(k) Number |
K181854 |
Device Name |
OssBuilder System |
Applicant |
Osstem Implant Co., Ltd.. |
66-16, Bansong-ro 513beon-gil, Haeundae-gu |
Busan,
KR
612-070
|
|
Applicant Contact |
Jungmin Yoo |
Correspondent |
Hiossen Inc. |
85 Ben Fairless Dr. |
Fairless Hills,
PA
19030
|
|
Correspondent Contact |
Peter Lee |
Regulation Number | 872.4880
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/11/2018 |
Decision Date | 05/07/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|