FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Bone Grafting Material, Dental, With Biologic Component
PMA: P040013
·
Supplement: S018
·
Decision Jul 11, 2014
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
- Supplement Number
- S018
- 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
- July 11, 2014
- Date Received
- February 29, 2012
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE REVISION OF THE GEM 21S PACKAGE INSERT.
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 |