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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 K121359
Device Name IPS 99 ONE AND IPS 99 CERAM
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 Number872.6660
Classification Product Code
EIH  
Date Received05/07/2012
Decision Date 07/27/2012
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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