Anker Dental Implant System - SB-III, ST And AT Series

Implant, Endosseous, Root-form

Alliance Global Technology Co., Ltd.

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.

Pre-market Notification Details

Device IDK142557
510k NumberK142557
Device Name:Anker Dental Implant System - SB-III, ST And AT Series
ClassificationImplant, Endosseous, Root-form
Applicant Alliance Global Technology Co., Ltd. 2F., No.92, Luke 5th Rd., Luzhu Dist., Kaohsiung City,  TW
ContactYayuan Chang
CorrespondentYayuan Chang
Alliance Global Technology Co., Ltd. 2F., No.92, Luke 5th Rd., Luzhu Dist., Kaohsiung City,  TW
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-11
Decision Date2015-09-21
Summary:summary

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