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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 K983453
Device Name PROCERA ALLCERAM FUSING MATERIAL
Applicant
Nobel Biocare Uas, Inc.
777 Oakmont Ln., Suite 100
Westmont,  IL  60559
Applicant Contact BETSY A BROWN
Correspondent
Nobel Biocare Uas, Inc.
777 Oakmont Ln., Suite 100
Westmont,  IL  60559
Correspondent Contact BETSY A BROWN
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/30/1998
Decision Date 11/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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