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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 FLOW (FORMERLY PEPGEN P-15 PUTTY)
Classification Namebone grafting material, dental, with biologic component
Generic Nameendosseous implant for bone filling and/or augmentation
Regulation Number872.3930
ApplicantCERAMED CORP.
PMA NumberP990033
Supplement NumberS002
Date Received01/02/2001
Decision Date08/09/2001
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to pepgen p-15 to form pepgen p-15 putty. The device, as modified, will be marketed under the trade name pepgen p-15 flow, but have the same indications for use as pepgen p-15.
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