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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 K983470
Device Name SUPER PORCELAIN STAIN- PURE WHITE
Applicant
Noritake Co., Inc.
1050 Connecticut Ave., NW
Washington,  DC  20036 -5339
Applicant Contact MARSHA C WERTZBERGER
Correspondent
Noritake Co., Inc.
1050 Connecticut Ave., NW
Washington,  DC  20036 -5339
Correspondent Contact MARSHA C WERTZBERGER
Regulation Number872.6660
Classification Product Code
EIH  
Date Received10/01/1998
Decision Date 12/22/1998
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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