FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Bone Grafting Material, Dental, With Biologic Component
PMA: P990033
·
Supplement: S016
·
Decision Dec 9, 2009
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Bone Grafting Material, Dental, With Biologic Component
- Trade Name
- PEPGEN P-15 FLOW
- PMA Number
- P990033
- Supplement Number
- S016
- 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
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 9, 2009
- Date Received
- November 9, 2009
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
CHANGE OF THE IN-PROCESS BIOBURDEN SPECIFICATION.
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 |