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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
Applicant
IVOCLAR VIVADENT AG
175 PINEVIEW DR.
AMHERST,  NY  14228
Applicant Contact DONNA MARIE HARTNETT
Correspondent
IVOCLAR VIVADENT AG
175 PINEVIEW DR.
AMHERST,  NY  14228
Correspondent Contact DONNA MARIE HARTNETT
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
EIH  
Date Received01/06/2012
Decision Date 10/18/2012
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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