PMA P930021S033
- Device
- BIORA EMDOGAIN(R)
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S033
- Product code
- NQA
- Decision date
- 2025-06-10
- Classification
- Dental
- Generic name
- Biologic material, dental
- Approval order statement
- addition of an alternative application needle (cannula) design for all Emdogain® packaging configurations.
Current openFDA PMA Record#
- Device
- BIORA EMDOGAIN(R)
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S033
- Product code
- NQA
- Generic name
- Biologic material, dental
- Decision date
- 2025-06-10
- Decision code
- APPR
- Date received
- 2025-03-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- addition of an alternative application needle (cannula) design for all Emdogain® packaging configurations.