FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Biologic Material, Dental
PMA: P930021
·
Supplement: S021
·
Decision Apr 23, 2019
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Biologic Material, Dental
- Trade Name
- Straumann Emdogain
- PMA Number
- P930021
- Supplement Number
- S021
- 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 23, 2019
- Date Received
- October 22, 2018
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval to change the test method for determining the calcium content of the intermediate bulk product and outsource the calcium content testing to Toxicon AB
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 |