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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 K052370
Device Name CP BRACKET SYSTEM
Applicant
Dentsply International
221 W. Philadelphia St., Suite 60
York,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
Dentsply International
221 W. Philadelphia St., Suite 60
York,  PA  17404
Correspondent Contact HELEN LEWIS
Regulation Number872.5470
Classification Product Code
DYW  
Date Received08/30/2005
Decision Date 11/01/2005
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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