The following data is part of a premarket notification filed by Alliance Global with the FDA for Anker Dental Implant System.
| Device ID | K131165 |
| 510k Number | K131165 |
| Device Name: | ANKER DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ALLIANCE GLOBAL 2F., NO.92, LUKE 5TH RD., LUZHU DIST., Kaohsiung City, TW 82151 |
| Contact | Yayuan Chang |
| Correspondent | Yayuan Chang ALLIANCE GLOBAL 2F., NO.92, LUKE 5TH RD., LUZHU DIST., Kaohsiung City, 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 | 2013-04-24 |
| Decision Date | 2013-11-14 |
| Summary: | summary |