Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K041402 |
Device Name |
MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS |
Applicant |
IMPLANT INNOVATIONS, INC. |
4555 RIVERSIDE DR. |
PALM BEACH GARDENS,
FL
33410
|
|
Applicant Contact |
JEANNETTE G DAILEY |
Correspondent |
IMPLANT INNOVATIONS, INC. |
4555 RIVERSIDE DR. |
PALM BEACH GARDENS,
FL
33410
|
|
Correspondent Contact |
JEANNETTE G DAILEY |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 05/26/2004 |
Decision Date | 06/16/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|