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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K093221
Device Name PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II
Applicant
Dentsply Intl., Inc.
Susquehanna Commerce Center
221 W. Philadelphia St., Suite 60
York,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
Dentsply Intl., Inc.
Susquehanna Commerce Center
221 W. Philadelphia St., Suite 60
York,  PA  17404
Correspondent Contact HELEN LEWIS
Regulation Number872.3750
Classification Product Code
DYH  
Subsequent Product Codes
EJF   NJM  
Date Received10/13/2009
Decision Date 10/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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