PMA P170029
- Device
- CALCIVIS Imaging System
- Applicant
- Calcivis Limited
- Product code
- QJX
- Decision date
- 2025-03-03
- Generic name
- Caries detection product with drug or biologic
- Approval order statement
- approval for the manufacturing scale up of the drug product (photoprotein) for use in the CALCIVIS Imaging System
Current openFDA PMA Record#
- Device
- CALCIVIS Imaging System
- Applicant
- Calcivis Limited
- PMA number
- P170029
- Supplement
- S004
- Product code
- QJX
- Generic name
- Caries detection product with drug or biologic
- Decision date
- 2025-03-03
- Decision code
- APPR
- Date received
- 2024-12-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the manufacturing scale up of the drug product (photoprotein) for use in the CALCIVIS Imaging System