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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 K113406
Device Name AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL
Applicant
DENTSPLY INTERNATIONAL, INC.
221 W. PHILADELPHIA ST., SE 60
SUSQUEHANNA COMMERCE CTR.
YORK,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
DENTSPLY INTERNATIONAL, INC.
221 W. PHILADELPHIA ST., SE 60
SUSQUEHANNA COMMERCE CTR.
YORK,  PA  17404
Correspondent Contact HELEN LEWIS
Regulation Number872.3660
Classification Product Code
ELW  
Date Received11/18/2011
Decision Date 02/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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