Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K201711 |
Device Name |
CARES Screw - Retained Bars and Bridges (SRBB) |
Applicant |
Medentika GmbH |
Hammweg 8-10 |
Hügelsheim,
DE
76549
|
|
Applicant Contact |
Alexandra Schulz |
Correspondent |
Straumann USA, LLC |
60 Minuteman Road |
Andover,
MA
01810
|
|
Correspondent Contact |
Jennifer M. Jackson |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 06/23/2020 |
Decision Date | 12/08/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|