NON-EUGENOL TEMPORARY CEMENT

Zinc Oxide Eugenol

J. MORITA USA, INC.

The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Non-eugenol Temporary Cement.

Pre-market Notification Details

Device IDK020158
510k NumberK020158
Device Name:NON-EUGENOL TEMPORARY CEMENT
ClassificationZinc Oxide Eugenol
Applicant J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington,  DC  20005
ContactKeith A Barritt
CorrespondentKeith A Barritt
J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington,  DC  20005
Product CodeEMB  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-17
Decision Date2002-03-07

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