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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Plastic, Orthodontic
510(k) Number K053055
Device Name ORTHODONTIC POLYMER COMPOSITE BRACKET
Applicant
Gestenco International AB
14 Fridkullagatan
Goteborg,  SE SE 400 22
Applicant Contact GORAN STEEN
Correspondent
Gestenco International AB
14 Fridkullagatan
Goteborg,  SE SE 400 22
Correspondent Contact GORAN STEEN
Regulation Number872.5470
Classification Product Code
DYW  
Date Received10/31/2005
Decision Date 12/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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