ST Internal Fixture 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 Fixture System.

Pre-market Notification Details

Device IDK152787
510k NumberK152787
Device Name:ST Internal Fixture System
ClassificationImplant, Endosseous, Root-form
Applicant T-PLUS IMPLANT TECH. CO., LTD. NO. 41, WUQUAN 6TH RD.. WUGU DIST. New Taipei City,  TW 24889
ContactDana Cheng
CorrespondentDana Cheng
T-PLUS IMPLANT TECH. CO., LTD. NO. 41, WUQUAN 6TH RD.. WUGU DIST. New Taipei City,  TW 24889
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-25
Decision Date2016-07-22
Summary:summary

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