Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K151789 |
FOIA Releasable 510(k) |
K151789
|
Device Name |
LOCATOR F-Tx Attachment System |
Applicant |
ZEST ANCHORS, LLC |
2061 WINERIDGE PLACE |
ESCONDIDO,
CA
92029
|
|
Applicant Contact |
ANNIE WRIGHT |
Correspondent |
PAXMED INTERNATIONAL, LLC |
12264 EL CAMINO REAL |
SUITE 400 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
KEVIN A. THOMAS |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 07/01/2015 |
Decision Date | 03/04/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|