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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Zinc Oxide Eugenol
510(k) Number K020158
Device Name NON-EUGENOL TEMPORARY CEMENT
Applicant
J. MORITA USA, INC.
601 13TH STREET, N.W.
SUITE 500 NORTH
WASHINGTON,  DC  20005
Applicant Contact KEITH A BARRITT
Correspondent
J. MORITA USA, INC.
601 13TH STREET, N.W.
SUITE 500 NORTH
WASHINGTON,  DC  20005
Correspondent Contact KEITH A BARRITT
Regulation Number872.3275
Classification Product Code
EMB  
Date Received01/17/2002
Decision Date 03/07/2002
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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