CALCIVIS Imaging System
FDA premarket approval P170029/S004 · decided 2025-03-03
Approval details
- PMA number
- P170029
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CALCIVIS Imaging System
- Generic name
- Caries detection product with drug or biologic
- Applicant
- Calcivis Limited
- Date received
- 2024-12-03
- Decision date
- 2025-03-03
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- QJX
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Edinburgh
- Statement
- approval for the manufacturing scale up of the drug product (photoprotein) for use in the CALCIVIS Imaging System
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