Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K151588 |
Device Name |
maxFit II Dental Implant System |
Applicant |
Taiwan Implant Technology Company, Ltd. |
Kaohsiung Science Park Branch |
5F., No.63, Luke 2nd Rd., Luzhu Dist |
Kaohsiung,
TW
82151
|
|
Applicant Contact |
Ching-Chieh Huang |
Correspondent |
Taiwan Implant Technology Company, Ltd. |
Kaohsiung Science Park Branch |
5F., No.63, Luke 2nd Rd., Luzhu Dist |
Kaohsiung,
TW
82151
|
|
Correspondent Contact |
Ching-Chieh Huang |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/11/2015 |
Decision Date | 04/25/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|