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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,  LI FL-9494
Applicant Contact SANDRA CAKEBREAD
Correspondent
IVOCLAR VIVADENT AG
BENDERERSTRASSE 2
SCHAAN,  LI FL-9494
Correspondent 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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