Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K110778 |
Device Name |
BIODENTA CUSTOMIZED ABUTMENT |
Applicant |
BIODENTA SWISS AG |
TRAMSTRASSE 16 |
BERNECK,
CH
9442
|
|
Applicant Contact |
ANGELA BLACKWELL |
Correspondent |
BIODENTA SWISS AG |
TRAMSTRASSE 16 |
BERNECK,
CH
9442
|
|
Correspondent Contact |
ANGELA BLACKWELL |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 03/21/2011 |
Decision Date | 07/29/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|