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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K020157
Device Name TEMPORARY CROWN AND BRIDGE MATERIAL
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 Number872.3770
Classification Product Code
EBG  
Date Received01/17/2002
Decision Date 03/04/2002
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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