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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, PEPGEN P-15 FLOW & PEPGEN P-15 PUTTY
Classification Namebone grafting material, dental, with biologic component
Generic Nameendosseous implant for bone filling and/or augmentation
Regulation Number872.3930
ApplicantDENTSPLY INTL.
PMA NumberP990033
Supplement NumberS014
Date Received01/16/2007
Decision Date08/09/2007
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: distributor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to relocate the manufacturing site to dentsply specialty materials located in york pennsylvania.
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