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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 DENTAL BONE GRAFTING MATERIAL AND BIOLOGIC COMPONENT
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 NumberS007
Date Received05/22/2006
Decision Date06/06/2006
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the change in indication for use - the device is no longer intended for reuse after resterilization and will be labeled as a single use only device.
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