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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 K090476
Device Name SYNTEC ORTHODONTIC MINI SCREW
Applicant
Syntec Scientific Corp.
3f1. 96 Chung Hsiao E. Rd.
Sec. 3
Taipei City,  TW 106
Applicant Contact SUSAN CHENG
Correspondent
Syntec Scientific Corp.
3f1. 96 Chung Hsiao E. Rd.
Sec. 3
Taipei City,  TW 106
Correspondent Contact SUSAN CHENG
Regulation Number872.3640
Classification Product Code
OAT  
Date Received02/24/2009
Decision Date 06/18/2009
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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