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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 K051705
Device Name IPS E.MAX CAD/IPS E.MAX ZIRCAD
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 Received06/24/2005
Decision Date 10/14/2005
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
Recalls CDRH Recalls
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