IPS EMPRESS COSMO INGOT

Powder, Porcelain

IVOCLAR NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Ips Empress Cosmo Ingot.

Pre-market Notification Details

Device IDK972827
510k NumberK972827
Device Name:IPS EMPRESS COSMO INGOT
ClassificationPowder, Porcelain
Applicant IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
ContactPeter P Mancuso
CorrespondentPeter P Mancuso
IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-30
Decision Date1997-09-17

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