Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K080864 |
Device Name |
CAM STRUCTSURE PRECISION MILLED BARS |
Applicant |
BIOMET 3I, INC. |
4555 RIVERSIDE DR. |
PALM BEACH GARDENS,
FL
33410
|
|
Applicant Contact |
TAMARA WEST |
Correspondent |
BIOMET 3I, INC. |
4555 RIVERSIDE DR. |
PALM BEACH GARDENS,
FL
33410
|
|
Correspondent Contact |
TAMARA WEST |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 03/28/2008 |
Decision Date | 07/21/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|