Straumann Emdogain
FDA premarket approval P930021/S032 · decided 2023-06-21
Approval details
- PMA number
- P930021
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Straumann Emdogain
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2023-05-25
- Decision date
- 2023-06-21
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- Relocation of Visual Inspection and Blistering activities to new cleanrooms in house K to release space for manufacturing of other products in the clean room areas but will also be beneficial for the Emdogain process since it will lead to a better material flow between clean room areas and warehouse.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.