Syntec Orthodontic Mini Screw Extended System

Implant, Endosseous, Orthodontic

Syntec Scientific Corporation

The following data is part of a premarket notification filed by Syntec Scientific Corporation with the FDA for Syntec Orthodontic Mini Screw Extended System.

Pre-market Notification Details

Device IDK202790
510k NumberK202790
Device Name:Syntec Orthodontic Mini Screw Extended System
ClassificationImplant, Endosseous, Orthodontic
Applicant Syntec Scientific Corporation No.2, Kung San Road Chuan Shing Industrial Zone, Shen Kang Chang Hua,  TW 50971
ContactNicole Tseng
CorrespondentNicole Tseng
Syntec Scientific Corporation - Taipei Office 3F., No.96, Sec. 3, Zhongxio East Road Da'An Dist., Taipei,  TW 10652
Product CodeOAT  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-22
Decision Date2021-09-17

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