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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bone grafting material, synthetic
510(k) Number K113282
Device Name CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO
Original Applicant
RIEMSER ARZEIMITTEL AG
5105 fairoaks rd
durham,  NC  27712
Original Contact james m clinton
Regulation Number872.3930
Classification Product Code
LYC  
Date Received11/07/2011
Decision Date 09/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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