FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Biologic Material, Dental
PMA: P930021
·
Decision Sep 30, 1996
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Biologic Material, Dental
- Trade Name
- BIORA EMDOGAIN(R)
- PMA Number
- P930021
- Device Class
- FDA Class 3
- Product Code
- NQA
- Generic Name
- Biologic material, dental
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Advisory Committee
- Dental
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 30, 1996
- Date Received
- July 19, 1993
- Expedited Review
- N
- Docket Number
- 96M-0482
Advisory Committee Statement
APPROVAL FOR THE EMDOGAIN
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 |
|---|---|---|---|
| NQA | Biologic Material, Dental | FDA class 3 | Dental |