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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 K103556
Device Name IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
Applicant
Ivoclar Vivadent, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Applicant Contact DONNA MARIE HARTNETT
Correspondent
Ivoclar Vivadent, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Correspondent Contact DONNA MARIE HARTNETT
Regulation Number872.6660
Classification Product Code
EIH  
Date Received12/02/2010
Decision Date 04/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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