Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K203456 |
Device Name |
Straumann CARES M-Series CAD/CAM System |
Applicant |
Institut Straumann AG |
Peter Merian-Weg 12 |
Basel,
CH
CH-4002
|
|
Applicant Contact |
Gordon Dodds |
Correspondent |
Straumann USA, LLC |
60 Minuteman Road |
Andover,
ME
01810
|
|
Correspondent Contact |
Jennifer M Jackson |
Regulation Number | 872.3630
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/23/2020 |
Decision Date | 06/23/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|