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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA 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
ApplicantBIOMIMETIC THERAPEUTICS, INC.
PMA NumberP040013
Supplement NumberS005
Date Received07/31/2006
Decision Date08/21/2006
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the bmpi sterility test method to extend the expiry date to 36 months and is indicated to treat the following periodontally related defects: 1) intrabony periodontal defects; 2) furcation periodontal defects; and 3) gingival recession associated with periodontal defects.
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