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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name implant, endosseous, orthodontic
510(k) Number K202790
Device Name Syntec Orthodontic Mini Screw Extended System
Applicant
Syntec Scientific Corporation
No.2, Kung San Road Chuan Shing Industrial Zone, Shen Kang
Chang Hua,  TW 50971
Applicant Contact Nicole Tseng
Correspondent
Syntec Scientific Corporation - Taipei Office
3F., No.96, Sec. 3, Zhongxio East Road Da'An Dist.,
Taipei,  TW 10652
Correspondent Contact Nicole Tseng
Regulation Number872.3640
Classification Product Code
OAT  
Date Received09/22/2020
Decision Date 09/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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