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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 K100250
Device Name XCERAM
Original Applicant
XCERAMUSA
8726 ferrara court
naples,  FL  34114
Original Contact daniel kamm
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/27/2010
Decision Date 04/08/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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