FDA 510(k) Application Details - K072057

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K072057
Device Name Bone Grafting Material, Synthetic
Applicant DENTSPLY INTERNATIONAL, INC.
SUSQUEHANNA COMMERCE CTR., 221
W. PHILADELPHIA ST., SUITE 60
YORK, PA 17404 US
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Contact HELEN LEWIS
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 07/26/2007
Decision Date 08/06/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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