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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 K142001
Device Name SYNTEC WETALI ORTHODONTIC MINI SCREWS
Applicant
SYNTEC SCIENTIFIC CORPORATION - TAIPEI OFFICE
3F., NO. 96, SEC. 3, ZHONGXIO EAST ROAD DA'AN DIST.,
TAIPEI,  TW 10652
Applicant Contact KAVIN CHU
Correspondent
SYNTEC SCIENTIFIC CORPORATION - TAIPEI OFFICE
3F., NO. 96, SEC. 3, ZHONGXIO EAST ROAD DA'AN DIST.,
TAIPEI,  TW 10652
Correspondent Contact KAVIN CHU
Regulation Number872.3640
Classification Product Code
OAT  
Date Received07/23/2014
Decision Date 03/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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