The following data is part of a premarket notification filed by Alliance Global Technology Co., Ltd. with the FDA for Anker Dental Implant System - Sb-iii, St And At Series.
Device ID | K142557 |
510k Number | K142557 |
Device Name: | Anker Dental Implant System - SB-III, ST And AT Series |
Classification | Implant, Endosseous, Root-form |
Applicant | Alliance Global Technology Co., Ltd. 2F., No.92, Luke 5th Rd., Luzhu Dist., Kaohsiung City, TW |
Contact | Yayuan Chang |
Correspondent | Yayuan Chang Alliance Global Technology Co., Ltd. 2F., No.92, Luke 5th Rd., Luzhu Dist., Kaohsiung City, TW |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-11 |
Decision Date | 2015-09-21 |
Summary: | summary |