Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K033430 |
Device Name |
3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615 |
Applicant |
IMPLANT INNOVATIONS, INC. |
4555 RIVERSIDE DR. |
PALM BEACH GARDENS,
FL
33410
|
|
Applicant Contact |
TAMARA NELSON |
Correspondent |
IMPLANT INNOVATIONS, INC. |
4555 RIVERSIDE DR. |
PALM BEACH GARDENS,
FL
33410
|
|
Correspondent Contact |
TAMARA NELSON |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 10/28/2003 |
Decision Date | 11/07/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|