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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K043462
Device Name CZR PRESS LF
Applicant
Noritake Co., Inc.
3050 K St., NW, Suite 400
Washington,  DC  20007
Applicant Contact IVAN J WASSERMAN
Correspondent
Noritake Co., Inc.
3050 K St., NW, Suite 400
Washington,  DC  20007
Correspondent Contact IVAN J WASSERMAN
Regulation Number872.6660
Classification Product Code
EIH  
Date Received12/15/2004
Decision Date 01/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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