Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K161118 |
Device Name |
SIMPLANT Online Case Review and SIMPLANT Editor |
Applicant |
DENTSPLY SIRONA |
221 WEST PHILADELPHIA STREET |
SUITE 60 |
york,
PA
17404
|
|
Applicant Contact |
helen lewis |
Correspondent |
DENTSPLY SIRONA |
221 WEST PHILADELPHIA STREET |
SUITE 60 |
york,
PA
17404
|
|
Correspondent Contact |
helen lewis |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 04/20/2016 |
Decision Date | 07/28/2016 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|