IPS E.MAX PRESS MULTI

Powder, Porcelain

IVOCLAR VIVADENT AG

The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Ips E.max Press Multi.

Pre-market Notification Details

Device IDK120134
510k NumberK120134
Device Name:IPS E.MAX PRESS MULTI
ClassificationPowder, Porcelain
Applicant IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst,  NY  14228
ContactDonna M Hartnett
CorrespondentDonna M Hartnett
IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst,  NY  14228
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-17
Decision Date2012-06-25

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