Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K192401 |
Device Name |
Straumann Screw-Retained Abutments |
Applicant |
Straumann USA, LLC |
60 Minuteman Road |
Andover,
MA
01810
|
|
Applicant Contact |
Jennifer M Jackson |
Correspondent |
Straumann USA, LLC |
60 Minuteman Road |
Andover,
MA
01810
|
|
Correspondent Contact |
Chanrasmey White |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 09/03/2019 |
Decision Date | 04/06/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|