Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K060836 |
Device Name |
VISTADENT OC - VERSION 4 |
Applicant |
DENTSPLY INTL., INC. |
SUSQUEHANNA COMMERCE CENTER |
221W PHILADELPHIA ST. SUITE 60 |
YORK,
PA
17404
|
|
Applicant Contact |
HELEN LEWIS |
Correspondent |
DENTSPLY INTL., INC. |
SUSQUEHANNA COMMERCE CENTER |
221W PHILADELPHIA ST. SUITE 60 |
YORK,
PA
17404
|
|
Correspondent Contact |
HELEN LEWIS |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 03/28/2006 |
Decision Date | 10/27/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|