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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 K111107
Device Name SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE
Applicant
Noritake Co., Inc.
700 12 St., NW,
Suite 1100
Washington,  DC  20005
Applicant Contact IVAN WASSERMAN
Correspondent
Noritake Co., Inc.
700 12 St., NW,
Suite 1100
Washington,  DC  20005
Correspondent Contact IVAN WASSERMAN
Regulation Number872.6660
Classification Product Code
EIH  
Date Received04/20/2011
Decision Date 06/30/2011
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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