Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K152787 |
Device Name |
ST Internal Fixture System |
Applicant |
T-PLUS IMPLANT TECH. CO., LTD. |
NO. 41, WUQUAN 6TH RD.. WUGU DIST. |
NEW TAIPEI CITY,
TW
24889
|
|
Applicant Contact |
DANA CHENG |
Correspondent |
T-PLUS IMPLANT TECH. CO., LTD. |
NO. 41, WUQUAN 6TH RD.. WUGU DIST. |
NEW TAIPEI CITY,
TW
24889
|
|
Correspondent Contact |
DANA CHENG |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/25/2015 |
Decision Date | 07/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|