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Device | GEM 21S (GROWTH-FACTOR ENHANCED MATRIX |
Generic Name | Bone grafting material, dental, with biologic component |
Regulation Number | 872.3930 |
Applicant | Lynch Biologics LLC 5526 Joseph Street Franklin, TN 37064 |
PMA Number | P040013 |
Date Received | 03/12/2004 |
Decision Date | 11/18/2005 |
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
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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 |