Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K062542 |
Device Name |
Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX |
Applicant |
Z-Systems AG |
11234 EL CAMINO REAL |
STE: 200 |
SAN DIEGO,
CA
92024
|
|
Applicant Contact |
FLOYD G LARSON |
Correspondent |
Z-Systems AG |
11234 EL CAMINO REAL |
STE: 200 |
SAN DIEGO,
CA
92024
|
|
Correspondent Contact |
FLOYD G LARSON |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 08/30/2006 |
Decision Date | 10/29/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|