Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K151295 |
Device Name |
Biodenta Customized Abutment - Titanium |
Applicant |
BIODENTA SWISS AG |
TRAMSTRASSE 16 |
BERNECK,
CH
9442
|
|
Applicant Contact |
DAVID ELIER |
Correspondent |
BIODENTA SWISS AG |
TRAMSTRASSE 16 |
BERNECK,
CH
9442
|
|
Correspondent Contact |
DAVID ELIER |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 05/15/2015 |
Decision Date | 12/01/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|