Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K152559 |
Device Name |
TruAbutment DS |
Applicant |
TRUABUTMENT |
300 SOUTH HARBOR BLVD #520 |
ANAHEIM,
CA
92805
|
|
Applicant Contact |
BRANDON KIM |
Correspondent |
WITHUS GROUP INC |
2531 PEPPERDALE DRIVE |
ROWLAND HEIGHTS,
CA
91748
|
|
Correspondent Contact |
APRIL LEE |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 09/09/2015 |
Decision Date | 05/20/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|