Biologic Material, Dental
Basic Information
- Device Name
- Biologic Material, Dental
- Trade Name
- Straumann Emdogain
- PMA Number
- P930021
- Supplement Number
- S018
- 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 28, 2018
- Date Received
- December 15, 2017
- 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: 1) Revision of ventilation and implementation of cooling in clean rooms;2) Emdogain bulk tank will be covered by a sterile autoclave bag during storage time between compounding and filling;3) Implementation of heat-sealed autoclave pouch for sterilization and storage of stopper hopper;4) The sterile phase of the P2R2 autoclave program, validated for sterilization of filters and other equipment used for aseptic production, was increased from 20 to 25 min;5) Sampling and weighing method of the PGA has been changed to be conducted in plastic Nalgene bottles; 6) The rules for analysis and reference sampling for each sub batch of Emdogain were updated to reduce the overall number of samples taken per day;7) Specifications for nitrogen gas and compressed air were updated; and8) An alternative IPC method (IR spectroscopy) for protein content determination in Emdogain process intermediates has been validated and implemented.
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 |