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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
Generic NameBone grafting material, dental, with biologic component
Regulation Number872.3930
ApplicantCERAMED CORP.
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 
Docket Number 99M-4692
Notice Date 11/04/1999
Advisory Committee Dental
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S007 S008 S014 S015 S016 S017 
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