GEM 21S (GROWTH-FACTOR ENHANCED MATRIX
FDA premarket approval P040013 · decided 2005-11-18
Approval details
- PMA number
- P040013
- Trade name
- GEM 21S (GROWTH-FACTOR ENHANCED MATRIX
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Lynch Biologics, LLC
- Date received
- 2004-03-12
- Decision date
- 2005-11-18
- Days to decision
- 616 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- 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.
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