CALCIVIS Imaging System
FDA premarket approval P170029 · decided 2023-03-07
Approval details
- PMA number
- P170029
- Trade name
- CALCIVIS Imaging System
- Generic name
- Caries detection product with drug or biologic
- Applicant
- Calcivis Limited
- Date received
- 2017-09-26
- Decision date
- 2023-03-07
- Days to decision
- 1988 days
- Decision code
- APPR
- Product code
- QJX
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Edinburgh
- Statement
- Approval for The CALCIVIS Imaging System. The device 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 and treatment planning of demineralization associated with caries lesions.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.