Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K133327 |
Device Name |
SATURNO(TM) OVERDENTURE IMPLANT SYSTEM |
Applicant |
ZEST ANCHORS, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Applicant Contact |
LINDA SCHULZ |
Correspondent |
ZEST ANCHORS, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
LINDA SCHULZ |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 10/29/2013 |
Decision Date | 06/25/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|