Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K162004 |
Device Name |
PREMIUM Implant Systems SHELTA Implant Systems |
Applicant |
SWEDEN & MARTINA S.p.A. |
via veneto, 10 |
Due Carrare,
IT
35020
|
|
Applicant Contact |
Alessia Pezzato |
Correspondent |
SWEDEN & MARTINA S.p.A. |
via veneto, 10 |
Due Carrare,
IT
35020
|
|
Correspondent Contact |
Alessia Pezzato |
Regulation Number | 872.3630
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/20/2016 |
Decision Date | 12/05/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|