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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name material, tooth shade, resin
510(k) Number K121230
Device Name IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE
Original Applicant
IVOCLAR VIVADENT AG
bendererstrasse 2
schaan,  LI fl-9494
Original Contact sandra cakebread
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/24/2012
Decision Date 08/29/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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