Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K172430 |
Device Name |
ArgenIS Titanium Abutments |
Applicant |
Argen Corporation |
5855 Oberlin Drive |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
Paul Cascone |
Correspondent |
Sterngold Dental, LLC |
23 Frank Mossberg Drive |
Attleboro,
MA
02703
|
|
Correspondent Contact |
Gordon Craig |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 08/11/2017 |
Decision Date | 05/18/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|