Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K141120 |
Device Name |
ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM |
Applicant |
ZIMMER DENTAL INC. |
1900 ASTON AVE. |
CARLSBAD,
CA
92008 -7308
|
|
Applicant Contact |
MELISSA BURBAGE |
Correspondent |
ZIMMER DENTAL INC. |
1900 ASTON AVE. |
CARLSBAD,
CA
92008 -7308
|
|
Correspondent Contact |
MELISSA BURBAGE |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 04/30/2014 |
Decision Date | 07/29/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|