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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 NameGEM 21S (GROWTH-FACTOR ENHANCED MATRIX
Classification Namebone grafting material, dental, with biologic component
Generic Namebone grafting material
Regulation Number872.3930
ApplicantLUITPOLD PHARMACEUTICALS, INC.
PMA NumberP040013
Date Received03/12/2004
Decision Date11/18/2005
Product Code
NPZ[ Registered Establishments with NPZ ]
Docket Number 05M-0474
Notice Date 11/28/2005
Advisory Committee Dental
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 S003 S004 S005 S006 S008 S009 S011 S012 
S013 S014 S015 S016 S017 S018 S019 
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