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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DevicePEPGEN P-15
Classification Namebone grafting material, dental, with biologic component
Generic Namebone grafting material, dental, with biologic component
Regulation Number872.3930
12860 west cedar drive,
suite 108
lakewood, CO 80228
PMA NumberP990033
Date Received06/24/1999
Decision Date10/25/1999
Withdrawal Date 02/16/2016
Product Code
NPZ[ Registered Establishments with NPZ ]
Docket Number 99M-4692
Notice Date 11/04/1999
Advisory Committee Dental
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for PepGen P-15. This device is intended to be used for intrabony periodontal osseous defects due to moderate or severe peridontitis.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S007 S008 S014 S015 
S016 S017