Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K080128 |
Device Name |
SM-EXTRA WIDE (RBM) IMPLANT SYSTEM |
Applicant |
DIO DEPARTMENT DSI, INC. |
3540 WILSHIRE BLVD. |
SUITE 1104 |
LOS ANGELES,
CA
90010
|
|
Applicant Contact |
HYUNGICK KIM |
Correspondent |
DIO DEPARTMENT DSI, INC. |
3540 WILSHIRE BLVD. |
SUITE 1104 |
LOS ANGELES,
CA
90010
|
|
Correspondent Contact |
HYUNGICK KIM |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 01/17/2008 |
Decision Date | 05/14/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|