Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K122171 |
Device Name |
MS SA IMPLANT SYSTEM |
Applicant |
OSSTEM IMPLANT CO LTD |
85 BEN FAIRLESS DR. |
FAIRLESS HILLS,
PA
19030
|
|
Applicant Contact |
PATRICK LIM |
Correspondent |
OSSTEM IMPLANT CO LTD |
85 BEN FAIRLESS DR. |
FAIRLESS HILLS,
PA
19030
|
|
Correspondent Contact |
PATRICK LIM |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 07/23/2012 |
Decision Date | 11/16/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|