Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K132219 |
FOIA Releasable 510(k) |
K132219
|
Device Name |
STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN, |
Applicant |
STRAUMANN USA, LLC |
60 MINUTEMAN ROAD |
ANDOVER,
MA
01810
|
|
Applicant Contact |
JENNIFER M JACKSON |
Correspondent |
STRAUMANN USA, LLC |
60 MINUTEMAN ROAD |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
JENNIFER M JACKSON |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 07/17/2013 |
Decision Date | 02/21/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|