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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 AND PEPGEN P-15 FLOW
Classification Namebone grafting material, dental, with biologic component
Regulation Number872.3930
ApplicantDENTSPLY CERAMED DENTAL
PMA NumberP990033
Supplement NumberS004
Date Received04/22/2002
Decision Date06/14/2002
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the following indications for use; augmentation of bony defects of the alveolar ridge, filling tooth extraction sites, and sinus elevation grafting. The device, as modified, will be marketed under the trade names pepgen p-15 and pepgen p-15 flow.
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