Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K171532 |
Device Name |
TruBase S |
Applicant |
TruAbutment Inc. |
300 South Harbor Blvd #520 |
Anaheim,
CA
92805
|
|
Applicant Contact |
Brandon Kim |
Correspondent |
WithUS Group Inc |
106 Superior |
Irvine,
CA
92620
|
|
Correspondent Contact |
April Lee |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 05/25/2017 |
Decision Date | 09/11/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|