FDA PMA
FDA Class 2
Approved (Reclassification)
🇺🇸 United States
Bone Grafting Material, For Dental Bone Repair
PMA: P800035
·
Decision Mar 24, 1981
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Bone Grafting Material, For Dental Bone Repair
- Trade Name
- PERI-OSS
- PMA Number
- P800035
- Device Class
- FDA Class 2
- Product Code
- LPK
- Generic Name
- Bone grafting material, for dental bone repair
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Advisory Committee
- Dental
- Decision
- Approved (Reclassification)
- Decision Code
- APRL
- Decision Date
- March 24, 1981
- Date Received
- June 12, 1980
- Expedited Review
- N
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 |
|---|---|---|---|
| LPK | Bone Grafting Material, For Dental Bone Repair | FDA class 2 | Dental |