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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K120053
Device Name IPS E.MAX PRESS - ABUTMENT SOLUTIONS
Original Applicant
IVOCLAR VIVADENT AG
175 pineview dr.
amherst,  NY  14228
Original Contact donna marie hartnett
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
EIH  
Date Received01/09/2012
Decision Date 10/18/2012
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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