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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
Classification Namebone grafting material, dental, with biologic component
Regulation Number872.3930
ApplicantDENTSPLY CERAMED DENTAL
PMA NumberP990033
Supplement NumberS003
Date Received01/14/2002
Decision Date01/25/2002
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in manufacturer/vendor for the p-15 peptide.
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