Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K183106 |
Device Name |
TruAbutment DS |
Applicant |
TruAbutment Inc. |
17742 Cowan |
Irvine,
CA
92614
|
|
Applicant Contact |
Kiyoon Nam |
Correspondent |
TruAbutment Inc. |
17742 Cowan |
Irvine,
CA
92614
|
|
Correspondent Contact |
Chris Choi |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 11/08/2018 |
Decision Date | 01/29/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|