FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Bone Grafting Material, Dental, With Biologic Component
PMA: P040013
·
Decision Nov 18, 2005
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Bone Grafting Material, Dental, With Biologic Component
- Trade Name
- GEM 21S (GROWTH-FACTOR ENHANCED MATRIX
- PMA Number
- P040013
- Device Class
- FDA Class 3
- Product Code
- NPZ
- Generic Name
- Bone grafting material, dental, with biologic component
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Advisory Committee
- Dental
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 18, 2005
- Date Received
- March 12, 2004
- Expedited Review
- N
- Docket Number
- 05M-0474
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NPZ | Bone Grafting Material, Dental, With Biologic Component | FDA class 3 | Dental |