Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K072100 |
Device Name |
GC AADVA ABUTMENT |
Applicant |
GC AMERICA, INC. |
1025 EVERETT ROAD, SUITE 100 |
LAKE FOREST,
IL
60045
|
|
Applicant Contact |
H. CARL JENKINS |
Correspondent |
GC AMERICA, INC. |
1025 EVERETT ROAD, SUITE 100 |
LAKE FOREST,
IL
60045
|
|
Correspondent Contact |
H. CARL JENKINS |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 07/31/2007 |
Decision Date | 02/14/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|