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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.
 
DeviceGEM 21S (GROWTH-FACTOR ENHANCED MATRIX
Generic NameBone grafting material, dental, with biologic component
Regulation Number872.3930
ApplicantLynch Biologics LLC
5526 Joseph Street
Franklin, TN 37064
PMA NumberP040013
Date Received03/12/2004
Decision Date11/18/2005
Product Code NPZ 
Docket Number 05M-0474
Notice Date 11/28/2005
Advisory Committee Dental
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE GEM 21S (GROWTH-FACTOR ENHANCED MATRIX). THE DEVICE IS INDICATED TO TREAT THE FOLLOWING PERIODONTALLY RELATED DEFECTS: 1) INTRABONY PERIODONTAL DEFECTS 2) FURCATION PERIODONTAL DEFECTS 3) GINGIVAL RECESSION ASSOCIATED WITH PERIODONTAL DEFECTS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S002 S003 S004 S005 S006 S008 S009 S011 S012 S013 S014 
S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S027 
S028 S029 S030 S031 
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