FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Biologic Material, Dental
PMA: P930021
·
Supplement: S028
·
Decision Apr 4, 2023
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Biologic Material, Dental
- Trade Name
- Straumann Emdogain
- PMA Number
- P930021
- Supplement Number
- S028
- 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
- April 4, 2023
- Date Received
- December 10, 2021
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for the implementation of a new freeze room and a new cold room to increase storage capacity for raw materials, and intermediate and final products.
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 |