Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K061410 |
Device Name |
SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT |
Applicant |
ZIMMER DENTAL INC. |
11234 EL CAMINO REAL, |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
Floyd Larson |
Correspondent |
ZIMMER DENTAL INC. |
11234 EL CAMINO REAL, |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
Floyd Larson |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 05/22/2006 |
Decision Date | 09/08/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|