FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Bone Grafting Material, Dental, With Biologic Component
PMA: P990033
·
Decision Oct 25, 1999
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Bone Grafting Material, Dental, With Biologic Component
- Trade Name
- PEPGEN P-15
- PMA Number
- P990033
- 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- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- October 25, 1999
- Date Received
- June 24, 1999
- Expedited Review
- N
- Docket Number
- 99M-4692
Advisory Committee Statement
Approval for PepGen P-15. This device is intended to be used for intrabony periodontal osseous defects due to moderate or severe peridontitis.
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 |