Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K032263 |
Device Name |
3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR |
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 | 07/23/2003 |
Decision Date | 01/28/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|