Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K132209 |
Device Name |
IPS E.MAX CAD ABUTMENT SOLUTIONS |
Applicant |
IVOCLAR VIVADENT AG |
175 PINEVIEW DR. |
AMHERST,
NY
14228
|
|
Applicant Contact |
DONNA HARTNETT |
Correspondent |
IVOCLAR VIVADENT AG |
175 PINEVIEW DR. |
AMHERST,
NY
14228
|
|
Correspondent Contact |
DONNA HARTNETT |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 07/16/2013 |
Decision Date | 10/31/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|