Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K121709 |
Device Name |
ZFX DENTAL CAD SYSTEM |
Applicant |
ZIMMER DENTAL INC. |
1900 ASTON AVE. |
CARLSBAD,
CA
92008 -7308
|
|
Applicant Contact |
CECILIA SILVA |
Correspondent |
ZIMMER DENTAL INC. |
1900 ASTON AVE. |
CARLSBAD,
CA
92008 -7308
|
|
Correspondent Contact |
CECILIA SILVA |
Regulation Number | 872.3630
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/11/2012 |
Decision Date | 10/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|