Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K150938 |
Device Name |
Straumann® Dental Implant System ¿ Roxolid® SLA Implants |
Applicant |
STRAUMANN USA, LLC |
60 MINUTEMAN ROAD |
ANDOVER,
MA
01810
|
|
Applicant Contact |
CHRISTOPHER KLACZYK |
Correspondent |
STRAUMANN USA, LLC |
60 MINUTEMAN ROAD |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
CHRISTOPHER KLACZYK |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 04/07/2015 |
Decision Date | 07/24/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|