This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: CALCIVIS Imaging System
PMA Applicant: CALCIVIS Limited
Address: Nine Edinburgh BioQuarter, 9 Little France Road, Edinburgh, EH16 4UX, United Kingdom
Approval Date: March 7, 2023
Approval Letter: Approval Order
What is it?
The CALCIVIS Imaging System is used as an aid by dental health care providers to help detect and plan treatment for tooth decay, or caries lesions. The system includes a handheld imaging device with a camera and a syringe applicator. The syringe applicator dispenses the CALCIVIS photoprotein solution that intended to make active caries lesions stand out in the images.
How does it work?
The CALCIVIS Imaging System dispenses the CALCIVIS photoprotein onto teeth in a person’s mouth. The CALCIVIS photoprotein binds to free calcium minerals in the mouth that come from the mineral loss of enamel related to active caries lesions. The free calcium minerals combined with the CALCIVIS photoprotein give off a visible light that is captured by the camera in the handheld device. The images of the detected light on the patient’s teeth are used by the dental health care provider to identify active caries lesions and help develop a treatment plan.
When is it used?
The CALCIVIS Imaging System is intended for use by dental health care professionals for people ages 6 and older who have, or who are at risk of developing, mineral loss of enamel due to active caries lesions on the tooth surface.
What will it accomplish?
The system’s images are used to help dental health care providers to assess, diagnose, and plan treatment for caries lesions that could develop into cavities. The clinical study conducted for the CALCIVIS Imaging System measured whether visible light from the CALCIVIS photoprotein was present on tooth surfaces. The study then assessed how well this information correlated to findings for teeth that were also measured by dentists according to the International Caries Detection and Assessment System (ICDAS).
Based on 110 people imaged with the CALCIVIS Imaging System, there were images collected for 90 sound teeth with no visible lesions and 86 teeth with active caries lesions. Of the 90 sound teeth with no visible lesions, 88 also showed no emitted light from photoprotein, an agreement of 97.8%. Of the 86 teeth with active lesions, 78 were found to emit light from photoprotein, for a 90.7% agreement. These findings show CALCIVIS Imaging System was effective as an aid for identifying and planning treatment of dental caries.
When should it not be used?
There are no known reasons not to use the CALCIVIS Imaging System.
Additional information (including warnings, precautions, and adverse events):