Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K150295 |
Device Name |
LOCATOR RTx |
Applicant |
ZEST ANCHORS, INC. |
2061 WINERIDGE PL. |
ESCONDIDO,
CA
92029
|
|
Applicant Contact |
Annie Wrigth |
Correspondent |
PaxMed International, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Linda K Schulz |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 02/06/2015 |
Decision Date | 07/24/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|