Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K191382 |
Device Name |
IPS e.max CAD Abutment Solutions- extra systems |
Applicant |
Ivoclar Vivadent, AG |
Bendererstrasse 2 |
Schaan,
LI
FL-9494
|
|
Applicant Contact |
Sandra Cakebread |
Correspondent |
Ivoclar Vivadent, Inc. |
175 Pineview Drive |
Amherst,
NY
14228
|
|
Correspondent Contact |
Lori Aleshin |
Regulation Number | 872.3630
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/23/2019 |
Decision Date | 08/26/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|