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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
Applicant
IVOCLAR VIVADENT AG
bendererstrasse 2
schaan, 
Contact sandra cakebread
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/24/2012
Decision Date 08/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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