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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 K021416
Device Name AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL
Applicant
Dentsply Intl.
570 W. College Ave.
York,  PA  17405 -0872
Applicant Contact P. JEFFERY LEHN
Correspondent
Dentsply Intl.
570 W. College Ave.
York,  PA  17405 -0872
Correspondent Contact P. JEFFERY LEHN
Regulation Number872.3660
Classification Product Code
ELW  
Date Received05/03/2002
Decision Date 05/13/2002
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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