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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.
 
DevicePEPGEN P-15 AND PEPGEN P-15 FLOW
Classification Namebone grafting material, dental, with biologic component
Generic Namebone grafting material, dental, with biologic component
Regulation Number872.3930
Applicant
CERAMED CORP.
12860 west cedar drive,
suite 108
lakewood, CO 80228
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/instructions/shelf life/tradename
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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