Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K160519 |
Device Name |
Link Abutment for CEREC |
Applicant |
Osstem Implant Co., Ltd |
66-16, Bansong-ro 513beon-gil, Haeundae-gu |
Busan,
KR
612-070
|
|
Applicant Contact |
Hee Kwon |
Correspondent |
HIOSSEN INC. |
85 BEN FAIRLESS DR. |
FAIRLESS HILLS,
PA
19030
|
|
Correspondent Contact |
DAVID KIM |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 02/25/2016 |
Decision Date | 10/28/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|