The following data is part of a premarket notification filed by Alliance Global Technology Co., Ltd. with the FDA for Anker Ii Dental Implant System.
| Device ID | K152576 |
| 510k Number | K152576 |
| Device Name: | Anker II Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Alliance Global Technology Co., Ltd. 2F., No.92, Luke 5th Rd. Kaohsiung, TW 82151 |
| Contact | Yayuan Chang |
| Correspondent | Yayuan Chang Alliance Global Technology Co., Ltd. 2F., No.92, Luke 5th Rd. Kaohsiung, TW 82151 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-09 |
| Decision Date | 2016-06-02 |