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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., # 96, Sec. 3, Zhongxio E. Rd. Da'An Dist.,
Taipei,  TW 10652
Applicant Contact KAVIN CHU
Correspondent
Syntec Scientific Corporation - Taipei Office
3f., # 96, Sec. 3, Zhongxio E. Rd. 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
Predetermined Change
Control Plan Authorized		 No
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