Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K081575 |
Device Name |
HU/HS/HG PROSTHETIC SYSTEM |
Applicant |
OSSTEM IMPLANT CO.,LTD |
85 BEN FAIRLESS DR. |
FAIRLESS HILLS,
PA
19030
|
|
Applicant Contact |
MINJOO KIM |
Correspondent |
OSSTEM IMPLANT CO.,LTD |
85 BEN FAIRLESS DR. |
FAIRLESS HILLS,
PA
19030
|
|
Correspondent Contact |
MINJOO KIM |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 06/05/2008 |
Decision Date | 09/02/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|