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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powder, porcelain
510(k) Number K120134
Device Name IPS E.MAX PRESS MULTI
Original Applicant
IVOCLAR VIVADENT AG
175 pineview dr.
amherst,  NY  14228
Original Contact donna m hartnett
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/26/2012
Decision Date 06/25/2012
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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