Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K210356 |
Device Name |
Noris Medical Dental Implants System |
Applicant |
Noris Medical Ltd |
8 Hataasia |
Nesher,
IL
3688808
|
|
Applicant Contact |
Simha Sibony |
Correspondent |
Noris Medical Ltd |
8 Hataasia |
Nesher,
IL
3688808
|
|
Correspondent Contact |
Simha Sibony |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 02/08/2021 |
Decision Date | 02/04/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|