Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K123627 |
Device Name |
ET SMARTFIT ABUTMENT |
Applicant |
HIOSSEN INC. |
85 BEN FAIRLESS DRIVE |
FAIRLESS HILLS,
PA
19030
|
|
Applicant Contact |
PATRICK LIM |
Correspondent |
HIOSSEN INC. |
85 BEN FAIRLESS DRIVE |
FAIRLESS HILLS,
PA
19030
|
|
Correspondent Contact |
PATRICK LIM |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 11/23/2012 |
Decision Date | 06/28/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|