FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Biologic Material, Dental
PMA: P930021
·
Supplement: S001
·
Decision May 18, 1999
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Biologic Material, Dental
- Trade Name
- BIORA EMDOGAIN(R)
- PMA Number
- P930021
- Supplement Number
- S001
- 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
- May 18, 1999
- Date Received
- January 5, 1998
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for manufacturing and packaging changes for EMDOGAIN(R).
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 |