Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K925769 |
Device Name |
BRANEMARK SYSTEM ABUTMENTS COMPLETE |
Applicant |
NOBELPHARMA USA, INC. |
333 WEST WACKER DR. |
SUITE 2600 |
CHICAGO,
IL
60606
|
|
Applicant Contact |
THOMAS J MULDOON |
Correspondent |
NOBELPHARMA USA, INC. |
333 WEST WACKER DR. |
SUITE 2600 |
CHICAGO,
IL
60606
|
|
Correspondent Contact |
THOMAS J MULDOON |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 11/16/1992 |
Decision Date | 04/14/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|