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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K061427
Device Name PRE-IMPRESSION CONDITIONING SOLUTION
Applicant
Dentsply Intl.
221 W. Philadelphia St., Suite 60
York,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
Dentsply Intl.
221 W. Philadelphia St., Suite 60
York,  PA  17404
Correspondent Contact HELEN LEWIS
Regulation Number872.3660
Classification Product Code
ELW  
Subsequent Product Code
MVL  
Date Received05/23/2006
Decision Date 06/26/2006
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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