Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K180564 |
Device Name |
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases |
Applicant |
Medentika GmbH |
Hammweg 8-10 |
Huegelsheim,
DE
76549
|
|
Applicant Contact |
Gerhard Polzer |
Correspondent |
Straumann USA, LLC |
60 Minuteman Road |
Andover,
MA
01810
|
|
Correspondent Contact |
Jennifer M. Jackson |
Regulation Number | 872.3630 |
Classification Product Code |
|
Date Received | 03/05/2018 |
Decision Date | 01/07/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|