2023 FDA  Approved Devices

CALCIVIS Imaging System 

Calcivis imaging system can assist dentist for identifying and treating caries lesions or tooth decay. The system comprises a syringe applicator and a portable imaging device with a camera. The CALCIVIS photoprotein solution, that is designed to highlight active caries lesions in the pictures, is delivered via a syringe applicator.

Implications for usage:

1. Dental healthcare practitioners should use the Calcivis Imaging System on patients (6 years and older) who have or are at risk of developing demineralization linked to caries lesions on coronal tooth surfaces that are easily accessible. 
2. As a tool for assessment, diagnosis, and treatment planning of demineralization related to caries lesions, the Calcivis Imaging System is approved for use in providing images of active demineralization on tooth surfaces. 

Positioning

The CIS provides dentists a way to take and maintain pictures of tooth surfaces that have labelled free calcium ions, which is consistent with demineralization in active caries. This gives dentists the chance to put caries management techniques into practice. A definitive diagnosis of caries cannot be made solely based on the CIS pictures. They ought to be taken into account when creating a patient's care plan and comprehensive diagnostic workup. 

When is it used?

Dental practitioners are the intended users of the CALCIVIS Imaging System for patients aged 6 and above who have current caries lesions on their tooth surface that are causing mineral loss of enamel or who are at risk of developing such lesions.

What is it that it seeks to achieve?

Dental professionals can analyze, diagnose, and treat caries lesions that may become cavities with the aid of the system's photographs. The CALCIVIS Imaging System clinical research quantified the presence or absence of visible light originating from the CALCIVIS photoprotein on tooth surfaces. Next, based on the International Caries Detection and Assessment System (ICDAS), the study evaluated the degree to which the data correlated with measurements of teeth made by dentists.

CALCIVIS Imaging Device Kit Consists of: 

•  CALCIVIS Intra-oral Imaging Device 
• CALCIVIS Device Cradle 
•  CALCIVIS (Imaging) Software on USB card 
•  CALCIVIS User Manual  

Fig 2:shows the CALCIVIS Imaging Device loaded and assembled on a stand. 

Fig 3:An illustration of a typical "demine-map" image displayed chairside by the CALCIVIS imaging system.

Images were taken of 90 healthy teeth with no obvious lesions and 86 teeth with active caries lesions out of 110 individuals who underwent imaging with the CALCIVIS Imaging System. Eighty-eight of the ninety-nine sound teeth without obvious lesions also did not release light from photoprotein, indicating a 97.8% agreement.

FDA approved : 2023

Applicant: CALCIVIS pvt ltd.

REFERENCES

1. https://www.fda.gov/medical-devices/recently-approved-devices/calcivis-imaging-system-p170029
2. https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170029B.pdf
3. https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170029C.pdf