Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K132844 |
Device Name |
STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES |
Applicant |
STRAUMANN USA, LLC |
60 MINUTEMAN ROAD |
ANDOVER,
MA
01810
|
|
Applicant Contact |
CHRISTOPHER KLACZYK |
Correspondent |
STRAUMANN USA, LLC |
60 MINUTEMAN ROAD |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
CHRISTOPHER KLACZYK |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 09/11/2013 |
Decision Date | 01/15/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|