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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NamePEPGEN P-15
Classification Namebone grafting material, dental, with biologic component
Regulation Number872.3930
ApplicantCERAMED CORP.
PMA NumberP990033
Date Received06/24/1999
Decision Date10/25/1999
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 S004 S005 S007 S008 S014 S015 
S016 S017 
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