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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePEPGEN P-15 DENTAL BONE GRAFTING MATERIAL WITH BIOLOGIC COMPONENT
Classification Namebone grafting material, dental, with biologic component
Generic Nameendosseous implant for bone filling and/or augmentation
Regulation Number872.3930
ApplicantDENTSPLY FRIADENT CERAMED
PMA NumberP990033
Supplement NumberS008
Date Received08/30/2006
Decision Date10/05/2006
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at sterigenics, us, llc, queensbury, new york, to perform the ethylene oxide sterilization.
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