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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, AND 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 CERAMED DENTAL
PMA NumberP990033
Supplement NumberS005
Date Received11/12/2003
Decision Date03/15/2004
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) the addition of a paste form of pepgen p-15, 2) modification of the device labeling for all pepgen p-15 devices, and 3) changing of the contract manufacturer for the device carrier to hyaluron, inc. , woburn, massachusetts.
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