Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K120793 |
Device Name |
Z-LOOK3 EVO SLM |
Applicant |
Z-Systems AG |
11234 EL CAMINO REAL |
STE: 200 |
SAN DIEGO,
CA
92024
|
|
Applicant Contact |
LINDA SCHULZ |
Correspondent |
Z-Systems AG |
11234 EL CAMINO REAL |
STE: 200 |
SAN DIEGO,
CA
92024
|
|
Correspondent Contact |
LINDA SCHULZ |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 03/15/2012 |
Decision Date | 12/21/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|