Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K113404 |
Device Name |
DENTAL 3D PLANNING SOFTWARE |
Applicant |
SYMBYO DENTAL, LLC |
87 HULME CT APT.216 |
STANFORD,
CA
94305
|
|
Applicant Contact |
PARUL CHANSORIA |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/18/2011 |
Decision Date | 12/06/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|