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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.
 
DeviceGEM 21S (GROWTH-FACTOR ENHANCED MATRIX
Classification Namebone grafting material, dental, with biologic component
Generic Namebone grafting material, dental, with biologic component
Regulation Number872.3930
Applicant
Luitpold Pharmaceuticals, Inc.
800 adams avenue
suite 100
norristown, PA 19403
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 Product Yes
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
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 S020 S021 
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