BIORA EMDOGAIN(R)
FDA premarket approval P930021/S033 · decided 2025-06-10
Approval details
- PMA number
- P930021
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIORA EMDOGAIN(R)
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2025-03-12
- Decision date
- 2025-06-10
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- addition of an alternative application needle (cannula) design for all Emdogain® packaging configurations.
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