Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K111421 |
Device Name |
SIRONA DENTAL CAD/CAM SYSTEM |
Applicant |
SIRONA DENTAL SYSTEMS GMBH |
FABRIKSTRASSE 31 |
BENSHEIM,
DE
D-64625
|
|
Applicant Contact |
FRITZ KOLLE |
Correspondent |
SIRONA DENTAL SYSTEMS GMBH |
FABRIKSTRASSE 31 |
BENSHEIM,
DE
D-64625
|
|
Correspondent Contact |
FRITZ KOLLE |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 05/20/2011 |
Decision Date | 02/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|