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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
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 NumberS016
Date Received11/09/2009
Decision Date12/09/2009
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change of the in-process bioburden specification.
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