CALCIVIS Imaging System
FDA premarket approval P170029/S003 · decided 2023-10-13
Approval details
- PMA number
- P170029
- Supplement
- S003
- Supplement type
- Panel 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
- 2023-09-12
- Decision date
- 2023-10-13
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- QJX
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Edinburgh
- Statement
- Approval for the CALCIVIS Imaging System is intended to be used by dental healthcare professionals on patients (6 years and older) with, or at risk of developing, demineralization associated with caries lesions, on accessible coronal tooth surfaces. The CALCIVIS Imaging System is indicated for use to provide images of active demineralization on tooth surfaces, as an aid to the assessment, diagnosis, monitoring and treatment planning of demineralization associated with caries lesions.
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