ST Internal Implant System

Implant, Endosseous, Root-form

T-Plus Implant Tech. Co., Ltd.

The following data is part of a premarket notification filed by T-plus Implant Tech. Co., Ltd. with the FDA for St Internal Implant System.

Pre-market Notification Details

Device IDK190919
510k NumberK190919
Device Name:ST Internal Implant System
ClassificationImplant, Endosseous, Root-form
Applicant T-Plus Implant Tech. Co., Ltd. No.41, Wuquan 6th Rd., Wugu Dist. New Taipei County,  TW 24889
ContactDana Cheng
CorrespondentYuhua Chen
PuHsu Consulting Ltd. 7F., No.272, Jiankang Rd., Zhonghe Dist. New Taipei County,  TW 23553
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-09
Decision Date2020-02-27

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