DW238 #228-34A

Alloy, Other Noble Metal

IVOCLAR NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Dw238 #228-34a.

Pre-market Notification Details

Device IDK913068
510k NumberK913068
Device Name:DW238 #228-34A
ClassificationAlloy, Other Noble Metal
Applicant IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
ContactLloyd V Ziemendorf
CorrespondentLloyd V Ziemendorf
IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
Product CodeEJS  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-11
Decision Date1991-10-02

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