Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K150296 |
Device Name |
Biodenta Customized Abutment-Hybrid |
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 | 02/06/2015 |
Decision Date | 07/02/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|